83_FR_19851 83 FR 19764 - Amneal Holdings, LLC, and Impax Laboratories, Inc.; Analysis to Aid Public Comment

83 FR 19764 - Amneal Holdings, LLC, and Impax Laboratories, Inc.; Analysis to Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 83, Issue 87 (May 4, 2018)

Page Range19764-19767
FR Document2018-09546

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order-- embodied in the consent agreement--that would settle these allegations.

Federal Register, Volume 83 Issue 87 (Friday, May 4, 2018)
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19764-19767]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09546]


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FEDERAL TRADE COMMISSION

[File No. 181 0017]


Amneal Holdings, LLC, and Impax Laboratories, Inc.; Analysis to 
Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before May 29, 2018.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``In the Matter of 
Amneal Holdings, LLC, and Impax Laboratories, Inc.; File No. 181 0017'' 
on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/amnealimpaxdivest by following the 
instructions on the web-based form. If you prefer to file your comment 
on paper, write ``In the Matter of Amneal Holdings, LLC, and Impax 
Laboratories, Inc.; File No. 181 0017'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite 
CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Kari Wallace (202-326-3085), Bureau of 
Competition, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing consent orders to divest and providing for other relief to 
resolve the allegations in the complaint, having been filed with and 
accepted, subject to final approval, by the Commission, has been placed 
on the public record for a period of thirty (30) days. The following 
Analysis to Aid Public Comment describes the terms of the consent 
agreement, and the allegations in the complaint. An electronic copy of 
the full text of the consent agreement package can be obtained from the 
FTC Home Page (for April 27, 2018), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before May 29, 2018. 
Write ``In the Matter of Amneal Holdings, LLC, and Impax Laboratories, 
Inc.; File No. 181 0017'' on your comment. Your comment--including your 
name and your state--will be placed on the public record of this 
proceeding, including, to the extent practicable, on the public 
Commission website, at https://www.ftc.gov/policy/public-comments.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/amnealimpaxdivest by following the instructions on the web-based 
form. If this Notice appears at http://www.regulations.gov/#!home, you 
also may file a comment through that website.
    If you prefer to file your comment on paper, write ``In the Matter 
of Amneal Holdings, LLC, and Impax Laboratories, Inc.; File No. 181 
0017'' on your comment and on the envelope, and mail your comment to 
the following address: Federal Trade Commission, Office of the 
Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), 
Washington, DC 20580, or deliver your comment to the following address: 
Federal Trade Commission, Office of the Secretary, Constitution Center, 
400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC. 
20024. If possible, submit your paper comment to the Commission by 
courier or overnight service.
    Because your comment will be placed on the publicly accessible FTC 
website at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else's Social 
Security number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. You are also 
solely responsible for making sure that your comment does not include 
any sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC website at http://www.ftc.gov to read this Notice and 
the news release describing it. The FTC Act

[[Page 19765]]

and other laws that the Commission administers permit the collection of 
public comments to consider and use in this proceeding, as appropriate. 
The Commission will consider all timely and responsive public comments 
that it receives on or before May 29, 2018. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Agreement Containing Consent Orders To Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Amneal Holdings, LLC, Amneal Pharmaceuticals LLC 
(collectively, ``Amneal''), Impax Laboratories, Inc., and Impax 
Laboratories, LLC (collectively, ``Impax'') that is designed to remedy 
the anticompetitive effects resulting from Amneal's acquisition of 
equity interests of Impax. Under the terms of the proposed Consent 
Agreement, the parties are required to divest all of Impax's rights and 
assets related to the following seven products to ANI Pharmaceuticals, 
Inc. (``ANI''): Generic desipramine hydrochloride tablets; generic 
felbamate tablets; generic aspirin and dipyridamole extended release 
(``ER'') capsules; generic diclofenac sodium and misoprostol delayed 
release (``DR'') tablets; generic ezetimibe and simvastatin immediate 
release (``IR'') tablets; generic erythromycin tablets; and generic 
methylphenidate hydrochloride ER tablets. Pursuant to the Consent 
Agreement, the parties also are required to divest all of Impax's 
rights and assets related to generic azelastine nasal spray and generic 
olopatadine hydrochloride nasal spray to Perrigo Company plc 
(``Perrigo''), and to divest all of Impax's rights and assets related 
to generic fluocinonide-E cream to G&W Laboratories (``G&W'').
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments from interested persons. 
Comments received during this period will become part of the public 
record. After thirty days, the Commission will again evaluate the 
proposed Consent Agreement, along with the comments received, to make a 
final decision as to whether it should withdraw from the proposed 
Consent Agreement, modify it, or make final the Decision and Order 
(``Order'').
    Pursuant to agreements dated October 17, 2017, Amneal proposes to 
acquire the equity interests of Impax in a series of transactions 
valued at approximately $1.45 billion (the ``Proposed Acquisition''). 
The Commission alleges in its Complaint that the Proposed Acquisition, 
if consummated, would violate Section 7 of the Clayton Act, as amended, 
15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as 
amended, 15 U.S.C. 45, by lessening current competition in the 
following three U.S. markets: (1) Generic desipramine hydrochloride 
tablets; (2) generic ezetimibe and simvastatin IR tablets; and (3) 
generic felbamate tablets. The Commission also alleges that the 
Proposed Acquisition would violate the aforementioned statutes by 
lessening future competition in the following seven U.S. markets: (1) 
Generic aspirin and dipyridamole ER capsules; (2) generic azelastine 
nasal spray; (3) generic diclofenac sodium and misoprostol DR tablets; 
(4) generic erythromycin tablets; (5) generic fluocinonide-E cream; (6) 
generic methylphenidate hydrochloride ER tablets; and (7) generic 
olopatadine hydrochloride nasal spray. The proposed Consent Agreement 
will remedy the alleged violations by preserving the competition that 
otherwise would be eliminated by the Proposed Acquisition.

I. The Products and Structure of the Markets

    In human pharmaceutical markets, price generally decreases as the 
number of generic competitors increases. Prices continue to decrease 
incrementally with the entry of the second, third, fourth, and even 
fifth generic oral pharmaceutical competitor. Accordingly, the 
reduction in the number of suppliers within each relevant market has a 
direct and substantial effect on pricing.
    The Proposed Acquisition would reduce current competition in the 
markets for three products: (1) Generic desipramine hydrochloride 
tablets; (2) generic ezetimibe and simvastatin IR tablets; and (3) 
generic felbamate tablets.
    Desipramine hydrochloride, a tricyclic antidepressant, is sold by 
only three companies, other than Amneal and Impax, in the United 
States: Heritage Pharmaceuticals, Inc., Sandoz (a subsidiary of 
Novartis AG), and Teva Pharmaceutical Industries Ltd. (``Teva'').
    Ezetimibe and simvastatin is used to improve cholesterol and lower 
triglycerides. Only four companies currently sell generic ezetimibe and 
simvastatin IR tablets in the United States: Amneal, Impax, Dr. Reddy's 
Laboratories, and Teva.
    Felbamate is an anticonvulsant used in the treatment of epilepsy. 
For generic felbamate tablets, Alvogen, and Wallace Pharmaceuticals, 
Inc. (``Wallace'') are the only two companies in addition to Amneal and 
Impax that sell the product in the United States.
    The Proposed Acquisition also would reduce future competition in 
seven markets in which Amneal or Impax is a current competitor and the 
other is likely to enter the market: (1) Generic aspirin and 
dipyridamole ER capsules; (2) generic azelastine nasal spray; (3) 
generic diclofenac sodium and misoprostol DR tablets; (4) generic 
erythromycin tablets; (5) generic fluocinonide-E cream; (6) generic 
methylphenidate hydrochloride ER tablets; and (7) generic olopatadine 
hydrochloride nasal spray.
    Aspirin and dipyridamole is an antiplatelet therapy used to reduce 
the risk of stroke. Amneal is the only company currently selling 
generic aspirin and dipyridamole ER capsules in the United States, and 
Impax is one of only a limited number of suppliers capable of entering 
the market in the near future.
    Azelastine nasal spray is used to treat seasonal allergies. Impax 
partners with Perrigo to sell generic azelastine nasal spray. In 
addition, Wallace and Apotex Inc. also sell the product. Amneal, one of 
a limited number of suppliers capable of entering the market for 
generic azelastine nasal spray in the near future, already has 
tentative approval from the United States Food and Drug Administration 
(``FDA'').
    Diclofenac sodium and misoprostol is used to provide pain relief 
while minimizing gastrointestinal side effects. Four companies--Amneal, 
Teva, Sandoz, and Exela Pharma Sciences LLC (``Exela'')--have approved 
ANDAs to sell generic diclofenac sodium and misoprostol DR tablets in 
the United States. In addition, Greenstone LLC, a Pfizer subsidiary, 
sells an authorized generic version. Sandoz does not sell its product 
directly to customers and supplies only to a private labeler. The Exela 
product, marketed by both Eagle Pharmaceuticals, Inc. and Dash 
Pharmaceuticals LLC, has limited sales. Impax, partnered with Micro 
Labs Limited, is one of only a few suppliers capable of entering the 
market for generic diclofenac sodium and misoprostol DR tablets in the 
near future.
    Erythromycin is an antibiotic that had only one supplier, Arbor 
Pharmaceuticals, LLC, before the FDA approved Amneal's ANDA for generic 
erythromycin tablets in March of 2018. Amneal is the only supplier of 
generic erythromycin tablets in the United States. Impax is one of only 
a few

[[Page 19766]]

suppliers capable of entering the market for generic erythromycin in 
the near future.
    Fluocinonide-E cream, a topical corticosteroid used to reduce 
swelling, redness, itching, and allergic reactions, is sold in generic 
form by Impax, Alvogen, Sun Pharmaceutical Industries Ltd., and Teva in 
the United States. Amneal is one of very few suppliers capable of 
entering the market for generic fluocinonide-E cream in the near 
future.
    Methylphenidate hydrochloride is a central nervous system stimulant 
used to treat attention-deficit disorder and attention-deficit/
hyperactivity disorder. Only four companies currently sell generic 
methylphenidate hydrochloride ER tablets in the United States: Amneal, 
Mylan N.V., Teva, and Trigen Labs. Impax is one of only a limited 
number of suppliers capable of entering the market for generic 
methylphenidate hydrochloride ER tablets in the near future.
    Olopatadine hydrochloride nasal spray is used to treat seasonal 
allergies. Generic olopatadine hydrochloride nasal spray is sold in the 
United States by Sandoz, Apotex, and Impax partnered with Perrigo. 
Amneal is one of very few suppliers capable of entering the market in 
the near future.

II. Entry

    Entry into the ten markets at issue would not be timely, likely, or 
sufficient in magnitude, character, and scope to deter or counteract 
the anticompetitive effects of the Proposed Acquisition. The 
combination of drug development times and regulatory requirements, 
including approval by the FDA, is costly and lengthy.

III. Competitive Effects

    The Proposed Acquisition likely would cause significant 
anticompetitive harm to consumers by eliminating current competition 
between Amneal and Impax in the markets for generic desipramine 
hydrochloride tablets, generic ezetimibe and simvastatin IR tablets, 
and generic felbamate tablets. Generic desipramine hydrochloride 
tablets, generic ezetimibe and simvastatin IR tablets, and generic 
felbamate tablets are commodity products, and prices typically are 
inversely correlated with the number of competitors in each market. As 
the number of suppliers offering a therapeutically equivalent drug 
increases, the price for that drug generally decreases due to the 
direct competition between the existing suppliers and each additional 
supplier. Customers also raise concerns about their ability to source 
product at a competitive price if one supplier experiences 
manufacturing difficulties when there are fewer competitors in the 
market. The Proposed Acquisition would combine two of the only five 
companies selling generic desipramine hydrochloride tablets, and would 
combine two of the only four companies selling generic ezetimibe and 
simvastatin IR tablets and generic felbamate tablets, likely resulting 
in higher prices.
    But for the proposed Consent Agreement, the Proposed Acquisition 
also is likely to delay the introduction of beneficial competition, and 
subsequent price decreases, by eliminating future competition in seven 
markets in which either Amneal or Impax is a current competitor and the 
other is likely to enter. Multiple customers expressed concerns about 
the effect of the proposed merger on the market for generic aspirin and 
dipyridamole ER capsules, in which Amneal is the only current generic 
competitor and Impax is approved to enter. Impax is one of only three 
competitors providing generic azelastine nasal spray, and the imminent 
entry of Amneal likely would allow customers to negotiate more 
competitive prices and secure adequate supply. Impax is one of very few 
well-positioned entrants in the market for generic diclofenac sodium 
and misoprostol DR tablets, in which Amneal is one of four current 
competitors, and customers note that they would benefit from additional 
entry to negotiate pricing. Amneal is the only generic erythromycin 
tablet competitor, and Impax is one of a limited number of companies 
with products in development that upon entry would allow customers to 
negotiate lower prices. Amneal is the only foreseeable entrant in the 
market for generic fluocinonide-E cream, in which Impax is one of only 
three competitors. In the market for generic methylphenidate 
hydrochloride ER tablets, Amneal is one of four current competitors and 
Impax is one of few potential entrants. Finally, Amneal is one of only 
a few entrants poised to enter the market for generic olopatadine 
hydrochloride nasal spray, in which Impax is one of only three current 
competitors. Absent a remedy, the Proposed Acquisition likely would 
cause U.S. consumers to pay higher prices for the aforementioned 
generic products.

IV. The Consent Agreement

    As the Commission explained in its remedy review, The FTC's Merger 
Remedies 2006-2012: A Report of the Bureaus of Competition and 
Economics (hereafter ``The FTC Merger Remedies Study'') \1\, products 
made at third-party manufacturing sites are easier to divest and 
involve less risk than the technology transfer from in-house 
manufacturing to a new facility, and thus help ensure the success of 
divestitures. As a result, in most cases, if one of the products is 
developed or manufactured by a third party, the Commission will require 
divestiture of that product.
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    \1\ See The FTC's Merger Remedies 2006-2012: A Report of the 
Bureaus of Competition and Economics (Jan. 2017) at 36-37, https://www.ftc.gov/system/files/documents/reports/ftcs-merger-remedies-2006-2012-report-bureaus-competition-economics/p143100_ftc_merger_remedies_2006-2012.pdf.
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    Additionally, in mergers involving complex pharmaceutical products 
that are difficult to manufacture, the Commission generally will 
require the divestiture of an on-market product over a pipeline product 
to place the greater risk on the merging parties rather than the 
public, with exceptions for compelling and fact-specific reasons. When 
such compelling, fact-specific reasons exist, ``The goal of a 
divestiture is to put the product development effort (including any 
pending regulatory filings) in the hands of a new firm with the same 
ability and incentive to bring the pipeline product to market.'' \2\
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    \2\ See The FTC's Merger Remedies Study at 31.
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    The proposed Consent Agreement conforms to this approach and 
remedies the competitive concerns raised by the Proposed Acquisition in 
the generic azelastine nasal spray and generic olopatadine 
hydrochloride nasal spray markets by requiring Impax to return any 
rights and assets it has to its partner and ANDA-owner for these 
products, Perrigo. The proposed Consent Agreement remedies the 
competitive concerns raised by the Proposed Acquisition in the generic 
fluocinonide-E cream market by requiring Impax to return any rights and 
assets it has to its partner and ANDA-owner for this product, G&W. The 
parties must accomplish these divestitures no later than ten days after 
they consummate the Proposed Acquisition.
    The proposed Consent Agreement remedies the competitive concerns 
raised by the Proposed Acquisition in seven of the markets at issue by 
requiring Impax to divest all of its rights and assets related to those 
products to ANI. ANI is a pharmaceutical corporation that develops, 
manufacturers, sells, and distributes solid oral, liquid, and topical 
pharmaceutical products in the United States. ANI's track record in 
developing

[[Page 19767]]

and bringing to market pipeline products suggests that the divested 
products will be placed in the hands of a firm with the same ability 
and incentive to bring the products to market. As explained below, the 
Consent Agreement helps make that outcome more likely.
    For two of the products that both Amneal and Impax currently 
market, generic desipramine hydrochloride tablets and felbamate 
tablets, Impax will assign its contract manufacturing agreements to 
ANI. For the third currently-marketed product, Amneal will supply ANI 
with generic ezetimibe and simvastatin IR tablets for two years with 
the option to extend for two additional years.
    In four overlap markets in which Amneal has an on-market product 
and Impax has a product in development, Impax will divest its rights 
and assets to ANI rather than requiring Amneal to divest its on-market, 
in-house manufactured products. Each of these product markets has 
specific facts that warrant the divestiture of the Impax rights and 
assets rather than the Amneal product. Of note, three products--generic 
aspirin and dipyridamole ER capsules, generic methylphenidate 
hydrochloride ER tablets, and generic diclofenac sodium and misoprostol 
DR tablets--are more complicated to manufacture because they have 
extended or delayed release characteristics.
    For generic aspirin and dipyridamole ER capsules, Amneal is the 
only manufacturer with a product on the market. Amneal manufactures 
this product in-house. Impax received FDA approval for its ANDA in 2017 
and had expected to use a third-party manufacturer to launch its 
product. That manufacturer experienced some manufacturing difficulties 
and Impax had begun the process of developing the means to produce the 
product at its own facilities. With the divestiture, ANI will finalize 
the manufacturing process and expects to have the Impax drug on the 
market soon. Nevertheless, should ANI be unable to market its own 
version of this product by October 1, 2019, ANI has the option to 
source generic aspirin and dipyridamole ER capsules from Amneal until 
ANI obtains the necessary regulatory approvals or through March 1, 
2021, whichever date is earlier. This ensures that ANI will be able to 
market a competing product near the time Impax likely would have had 
the product on market, and provides the incentive for ANI to 
manufacture and market its own product. An alternative divestiture of 
the Amneal product would involve more risk and could jeopardize the 
only generic product on the market.
    The FDA approved Amneal's ANDA for generic methylphenidate 
hydrochloride ER tablets in February 2018. Impax also has an approved 
ANDA. Impax's product is contract manufactured, but the contract 
manufacturer needs to resolve manufacturing issues before it can resume 
manufacturing the product. It will be less risky for Impax to assign 
its manufacturing contract to ANI than to affect a technology transfer 
from Amneal for this complex product, and it will put the product in 
ANI's hands, which has the same ability and incentive as Impax to bring 
methylphenidate hydrochloride ER tablets to market. Thus, the proposed 
Order requires the divestiture of Impax's rights and assets to ANI.
    For generic diclofenac sodium and misoprostol DR tablets, Amneal 
has an on-market in-house manufactured product, and Impax is partnered 
with Micro Labs to commercialize a competing product. Impax holds only 
marketing rights to the product; Micro Labs is responsible for 
development and manufacturing. Impax will transfer its marketing 
agreement with Micro Labs to ANI, and Micro Labs will manufacture the 
product for ANI for the current contract term.
    For erythromycin tablets, Amneal launched its product in March 
2018, and only one other competitor, Arbor Pharmaceuticals, is 
currently selling erythromycin tablets. Amneal manufactures the 
erythromycin tablets in-house. Impax is one of a few companies 
developing the product, and once approved, it plans to outsource the 
manufacturing. Here, the easier-to-divest product is the Impax drug in 
development. Thus, Commission staff considers it prudent to leave the 
in-house Amneal-manufactured product with the merged firm, an ongoing 
and viable competitor to Arbor. Further, Impax will transfer all of its 
assets related to its development of erythromycin tablets to ANI, which 
has the same ability and incentive to bring a competing third 
erythromycin tablet to market.
    The proposed Order also requires Amneal to provide transitional 
services to ANI, Perrigo, and G&W to assist them in establishing their 
manufacturing capabilities and securing all of the necessary FDA 
approvals. These transitional services include technical assistance to 
manufacture the ten products at issue in substantially the same manner 
and quality employed or achieved by Impax. It also includes advice and 
training from knowledgeable employees of the parties. Under the 
proposed Consent Agreement, the Commission also will appoint an Interim 
Monitor.
    The Commission's goal in evaluating possible purchasers of divested 
assets is to maintain the competitive environment that existed prior to 
the Proposed Acquisition. If the Commission determines that ANI, 
Perrigo, and/or G&W are not acceptable acquirers, or that the manner of 
the divestitures is not acceptable, the proposed Order requires the 
parties to unwind the sale of rights to ANI, Perrigo, and/or G&W and 
then divest the affected products to a Commission-approved acquirer 
within six months of the date the Order becomes final. The proposed 
Order further allows the Commission to appoint a trustee in the event 
the parties fail to divest the products as required.
    The purpose of this analysis is to facilitate public comment on the 
proposed Consent Agreement, and it is not intended to constitute an 
official interpretation of the proposed Order or to modify its terms in 
any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018-09546 Filed 5-3-18; 8:45 am]
 BILLING CODE 6750-01-P



                                             19764                             Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices

                                             ensures notification to the FTC of                      Washington, DC 20580, or deliver your                 Washington, DC 20580, or deliver your
                                             changes in corporate status and                         comment to the following address:                     comment to the following address:
                                             mandates that Respondents submit an                     Federal Trade Commission, Office of the               Federal Trade Commission, Office of the
                                             initial compliance report to the FTC.                   Secretary, Constitution Center, 400 7th               Secretary, Constitution Center, 400 7th
                                             Part VII requires Respondents to retain                 Street SW, 5th Floor, Suite 5610 (Annex               Street SW, 5th Floor, Suite 5610 (Annex
                                             documents relating to its compliance                    D), Washington, DC 20024.                             D), Washington, DC. 20024. If possible,
                                             with the order for a five (5) year period.              FOR FURTHER INFORMATION CONTACT: Kari                 submit your paper comment to the
                                             Part VIII mandates that Respondents                     Wallace (202–326–3085), Bureau of                     Commission by courier or overnight
                                             make available to the FTC information                   Competition, 600 Pennsylvania Avenue                  service.
                                             or subsequent compliance reports, as                    NW, Washington, DC 20580.                                Because your comment will be placed
                                             requested. Part IX is a provision                                                                             on the publicly accessible FTC website
                                                                                                     SUPPLEMENTARY INFORMATION: Pursuant
                                             ‘‘sunsetting’’ the order after twenty (20)                                                                    at https://www.ftc.gov, you are solely
                                                                                                     to Section 6(f) of the Federal Trade
                                             years, with certain exceptions.                                                                               responsible for making sure that your
                                                                                                     Commission Act, 15 U.S.C. 46(f), and
                                                The purpose of this analysis is to aid                                                                     comment does not include any sensitive
                                                                                                     FTC Rule 2.34, 16 CFR 2.34, notice is
                                             public comment on the proposed order.                                                                         or confidential information. In
                                                                                                     hereby given that the above-captioned
                                             It is not intended to constitute an                                                                           particular, your comment should not
                                                                                                     consent agreement containing consent                  include any sensitive personal
                                             official interpretation of the complaint                orders to divest and providing for other
                                             or proposed order, or to modify in any                                                                        information, such as your or anyone
                                                                                                     relief to resolve the allegations in the              else’s Social Security number; date of
                                             way the proposed order’s terms.                         complaint, having been filed with and                 birth; driver’s license number or other
                                               By direction of the Commission.                       accepted, subject to final approval, by               state identification number, or foreign
                                             Donald S. Clark,                                        the Commission, has been placed on the                country equivalent; passport number;
                                             Secretary.                                              public record for a period of thirty (30)             financial account number; or credit or
                                             [FR Doc. 2018–09545 Filed 5–3–18; 8:45 am]              days. The following Analysis to Aid                   debit card number. You are also solely
                                             BILLING CODE 6750–01–P                                  Public Comment describes the terms of                 responsible for making sure that your
                                                                                                     the consent agreement, and the                        comment does not include any sensitive
                                                                                                     allegations in the complaint. An                      health information, such as medical
                                             FEDERAL TRADE COMMISSION                                electronic copy of the full text of the               records or other individually
                                                                                                     consent agreement package can be                      identifiable health information. In
                                             [File No. 181 0017]
                                                                                                     obtained from the FTC Home Page (for                  addition, your comment should not
                                             Amneal Holdings, LLC, and Impax                         April 27, 2018), on the World Wide                    include any ‘‘trade secret or any
                                             Laboratories, Inc.; Analysis to Aid                     Web, at https://www.ftc.gov/news-                     commercial or financial information
                                             Public Comment                                          events/commission-actions.                            which . . . is privileged or
                                                                                                        You can file a comment online or on                confidential’’—as provided by Section
                                             AGENCY:    Federal Trade Commission.                    paper. For the Commission to consider                 6(f) of the FTC Act, 15 U.S.C. 46(f), and
                                             ACTION:   Proposed Consent Agreement.                   your comment, we must receive it on or                FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
                                                                                                     before May 29, 2018. Write ‘‘In the                   including in particular competitively
                                             SUMMARY:    The consent agreement in this               Matter of Amneal Holdings, LLC, and
                                             matter settles alleged violations of                                                                          sensitive information such as costs,
                                                                                                     Impax Laboratories, Inc.; File No. 181                sales statistics, inventories, formulas,
                                             federal law prohibiting unfair methods                  0017’’ on your comment. Your
                                             of competition. The attached Analysis to                                                                      patterns, devices, manufacturing
                                                                                                     comment—including your name and                       processes, or customer names.
                                             Aid Public Comment describes both the                   your state—will be placed on the public                  Comments containing material for
                                             allegations in the complaint and the                    record of this proceeding, including, to              which confidential treatment is
                                             terms of the consent order—embodied                     the extent practicable, on the public                 requested must be filed in paper form,
                                             in the consent agreement—that would                     Commission website, at https://                       must be clearly labeled ‘‘Confidential,’’
                                             settle these allegations.                               www.ftc.gov/policy/public-comments.                   and must comply with FTC Rule 4.9(c).
                                             DATES: Comments must be received on                        Postal mail addressed to the                       In particular, the written request for
                                             or before May 29, 2018.                                 Commission is subject to delay due to                 confidential treatment that accompanies
                                             ADDRESSES: Interested parties may file a                heightened security screening. As a                   the comment must include the factual
                                             comment online or on paper, by                          result, we encourage you to submit your               and legal basis for the request, and must
                                             following the instructions in the                       comments online. To make sure that the                identify the specific portions of the
                                             Request for Comment part of the                         Commission considers your online                      comment to be withheld from the public
                                             SUPPLEMENTARY INFORMATION section                       comment, you must file it at https://                 record. See FTC Rule 4.9(c). Your
                                             below. Write: ‘‘In the Matter of Amneal                 ftcpublic.commentworks.com/ftc/                       comment will be kept confidential only
                                             Holdings, LLC, and Impax Laboratories,                  amnealimpaxdivest by following the                    if the General Counsel grants your
                                             Inc.; File No. 181 0017’’ on your                       instructions on the web-based form. If                request in accordance with the law and
                                             comment, and file your comment online                   this Notice appears at http://                        the public interest. Once your comment
                                             at https://ftcpublic.commentworks.com/                  www.regulations.gov/#!home, you also                  has been posted on the public FTC
                                             ftc/amnealimpaxdivest by following the                  may file a comment through that                       website—as legally required by FTC
                                             instructions on the web-based form. If                  website.                                              Rule 4.9(b)—we cannot redact or
                                             you prefer to file your comment on                         If you prefer to file your comment on              remove your comment from the FTC
                                             paper, write ‘‘In the Matter of Amneal                  paper, write ‘‘In the Matter of Amneal                website, unless you submit a
amozie on DSK3GDR082PROD with NOTICES




                                             Holdings, LLC, and Impax Laboratories,                  Holdings, LLC, and Impax Laboratories,                confidentiality request that meets the
                                             Inc.; File No. 181 0017’’ on your                       Inc.; File No. 181 0017’’ on your                     requirements for such treatment under
                                             comment and on the envelope, and mail                   comment and on the envelope, and mail                 FTC Rule 4.9(c), and the General
                                             your comment to the following address:                  your comment to the following address:                Counsel grants that request.
                                             Federal Trade Commission, Office of the                 Federal Trade Commission, Office of the                  Visit the FTC website at http://
                                             Secretary, 600 Pennsylvania Avenue                      Secretary, 600 Pennsylvania Avenue                    www.ftc.gov to read this Notice and the
                                             NW, Suite CC–5610 (Annex D),                            NW, Suite CC–5610 (Annex D),                          news release describing it. The FTC Act


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                                                                               Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices                                            19765

                                             and other laws that the Commission                      of transactions valued at approximately               felbamate tablets, Alvogen, and Wallace
                                             administers permit the collection of                    $1.45 billion (the ‘‘Proposed                         Pharmaceuticals, Inc. (‘‘Wallace’’) are
                                             public comments to consider and use in                  Acquisition’’). The Commission alleges                the only two companies in addition to
                                             this proceeding, as appropriate. The                    in its Complaint that the Proposed                    Amneal and Impax that sell the product
                                             Commission will consider all timely                     Acquisition, if consummated, would                    in the United States.
                                             and responsive public comments that it                  violate Section 7 of the Clayton Act, as                 The Proposed Acquisition also would
                                             receives on or before May 29, 2018. For                 amended, 15 U.S.C. 18, and Section 5 of               reduce future competition in seven
                                             information on the Commission’s                         the Federal Trade Commission Act, as                  markets in which Amneal or Impax is a
                                             privacy policy, including routine uses                  amended, 15 U.S.C. 45, by lessening                   current competitor and the other is
                                             permitted by the Privacy Act, see                       current competition in the following                  likely to enter the market: (1) Generic
                                             https://www.ftc.gov/site-information/                   three U.S. markets: (1) Generic                       aspirin and dipyridamole ER capsules;
                                             privacy-policy.                                         desipramine hydrochloride tablets; (2)                (2) generic azelastine nasal spray; (3)
                                                                                                     generic ezetimibe and simvastatin IR                  generic diclofenac sodium and
                                             Analysis of Agreement Containing                                                                              misoprostol DR tablets; (4) generic
                                                                                                     tablets; and (3) generic felbamate tablets.
                                             Consent Orders To Aid Public Comment                                                                          erythromycin tablets; (5) generic
                                                                                                     The Commission also alleges that the
                                                The Federal Trade Commission                         Proposed Acquisition would violate the                fluocinonide-E cream; (6) generic
                                             (‘‘Commission’’) has accepted, subject to               aforementioned statutes by lessening                  methylphenidate hydrochloride ER
                                             final approval, an Agreement                            future competition in the following                   tablets; and (7) generic olopatadine
                                             Containing Consent Orders (‘‘Consent                    seven U.S. markets: (1) Generic aspirin               hydrochloride nasal spray.
                                             Agreement’’) from Amneal Holdings,                      and dipyridamole ER capsules; (2)                        Aspirin and dipyridamole is an
                                             LLC, Amneal Pharmaceuticals LLC                         generic azelastine nasal spray; (3)                   antiplatelet therapy used to reduce the
                                             (collectively, ‘‘Amneal’’), Impax                       generic diclofenac sodium and                         risk of stroke. Amneal is the only
                                             Laboratories, Inc., and Impax                           misoprostol DR tablets; (4) generic                   company currently selling generic
                                             Laboratories, LLC (collectively,                        erythromycin tablets; (5) generic                     aspirin and dipyridamole ER capsules
                                             ‘‘Impax’’) that is designed to remedy the               fluocinonide-E cream; (6) generic                     in the United States, and Impax is one
                                             anticompetitive effects resulting from                  methylphenidate hydrochloride ER                      of only a limited number of suppliers
                                             Amneal’s acquisition of equity interests                tablets; and (7) generic olopatadine                  capable of entering the market in the
                                             of Impax. Under the terms of the                        hydrochloride nasal spray. The                        near future.
                                             proposed Consent Agreement, the                         proposed Consent Agreement will                          Azelastine nasal spray is used to treat
                                             parties are required to divest all of                   remedy the alleged violations by                      seasonal allergies. Impax partners with
                                             Impax’s rights and assets related to the                preserving the competition that                       Perrigo to sell generic azelastine nasal
                                             following seven products to ANI                         otherwise would be eliminated by the                  spray. In addition, Wallace and Apotex
                                             Pharmaceuticals, Inc. (‘‘ANI’’): Generic                Proposed Acquisition.                                 Inc. also sell the product. Amneal, one
                                             desipramine hydrochloride tablets;                                                                            of a limited number of suppliers capable
                                             generic felbamate tablets; generic                      I. The Products and Structure of the                  of entering the market for generic
                                             aspirin and dipyridamole extended                       Markets                                               azelastine nasal spray in the near future,
                                             release (‘‘ER’’) capsules; generic                         In human pharmaceutical markets,                   already has tentative approval from the
                                             diclofenac sodium and misoprostol                       price generally decreases as the number               United States Food and Drug
                                             delayed release (‘‘DR’’) tablets; generic               of generic competitors increases. Prices              Administration (‘‘FDA’’).
                                             ezetimibe and simvastatin immediate                     continue to decrease incrementally with                  Diclofenac sodium and misoprostol is
                                             release (‘‘IR’’) tablets; generic                       the entry of the second, third, fourth,               used to provide pain relief while
                                             erythromycin tablets; and generic                       and even fifth generic oral                           minimizing gastrointestinal side effects.
                                             methylphenidate hydrochloride ER                        pharmaceutical competitor.                            Four companies—Amneal, Teva,
                                             tablets. Pursuant to the Consent                        Accordingly, the reduction in the                     Sandoz, and Exela Pharma Sciences LLC
                                             Agreement, the parties also are required                number of suppliers within each                       (‘‘Exela’’)—have approved ANDAs to
                                             to divest all of Impax’s rights and assets              relevant market has a direct and                      sell generic diclofenac sodium and
                                             related to generic azelastine nasal spray               substantial effect on pricing.                        misoprostol DR tablets in the United
                                             and generic olopatadine hydrochloride                      The Proposed Acquisition would                     States. In addition, Greenstone LLC, a
                                             nasal spray to Perrigo Company plc                      reduce current competition in the                     Pfizer subsidiary, sells an authorized
                                             (‘‘Perrigo’’), and to divest all of Impax’s             markets for three products: (1) Generic               generic version. Sandoz does not sell its
                                             rights and assets related to generic                    desipramine hydrochloride tablets; (2)                product directly to customers and
                                             fluocinonide-E cream to G&W                             generic ezetimibe and simvastatin IR                  supplies only to a private labeler. The
                                             Laboratories (‘‘G&W’’).                                 tablets; and (3) generic felbamate tablets.           Exela product, marketed by both Eagle
                                                The proposed Consent Agreement has                      Desipramine hydrochloride, a                       Pharmaceuticals, Inc. and Dash
                                             been placed on the public record for                    tricyclic antidepressant, is sold by only             Pharmaceuticals LLC, has limited sales.
                                             thirty days for receipt of comments from                three companies, other than Amneal                    Impax, partnered with Micro Labs
                                             interested persons. Comments received                   and Impax, in the United States:                      Limited, is one of only a few suppliers
                                             during this period will become part of                  Heritage Pharmaceuticals, Inc., Sandoz                capable of entering the market for
                                             the public record. After thirty days, the               (a subsidiary of Novartis AG), and Teva               generic diclofenac sodium and
                                             Commission will again evaluate the                      Pharmaceutical Industries Ltd. (‘‘Teva’’).            misoprostol DR tablets in the near
                                             proposed Consent Agreement, along                          Ezetimibe and simvastatin is used to               future.
                                             with the comments received, to make a                   improve cholesterol and lower                            Erythromycin is an antibiotic that had
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                                             final decision as to whether it should                  triglycerides. Only four companies                    only one supplier, Arbor
                                             withdraw from the proposed Consent                      currently sell generic ezetimibe and                  Pharmaceuticals, LLC, before the FDA
                                             Agreement, modify it, or make final the                 simvastatin IR tablets in the United                  approved Amneal’s ANDA for generic
                                             Decision and Order (‘‘Order’’).                         States: Amneal, Impax, Dr. Reddy’s                    erythromycin tablets in March of 2018.
                                                Pursuant to agreements dated October                 Laboratories, and Teva.                               Amneal is the only supplier of generic
                                             17, 2017, Amneal proposes to acquire                       Felbamate is an anticonvulsant used                erythromycin tablets in the United
                                             the equity interests of Impax in a series               in the treatment of epilepsy. For generic             States. Impax is one of only a few


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                                             19766                             Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices

                                             suppliers capable of entering the market                their ability to source product at a                  Bureaus of Competition and Economics
                                             for generic erythromycin in the near                    competitive price if one supplier                     (hereafter ‘‘The FTC Merger Remedies
                                             future.                                                 experiences manufacturing difficulties                Study’’) 1, products made at third-party
                                                Fluocinonide-E cream, a topical                      when there are fewer competitors in the               manufacturing sites are easier to divest
                                             corticosteroid used to reduce swelling,                 market. The Proposed Acquisition                      and involve less risk than the
                                             redness, itching, and allergic reactions,               would combine two of the only five                    technology transfer from in-house
                                             is sold in generic form by Impax,                       companies selling generic desipramine                 manufacturing to a new facility, and
                                             Alvogen, Sun Pharmaceutical Industries                  hydrochloride tablets, and would                      thus help ensure the success of
                                             Ltd., and Teva in the United States.                    combine two of the only four companies                divestitures. As a result, in most cases,
                                             Amneal is one of very few suppliers                     selling generic ezetimibe and                         if one of the products is developed or
                                             capable of entering the market for                      simvastatin IR tablets and generic                    manufactured by a third party, the
                                             generic fluocinonide-E cream in the                     felbamate tablets, likely resulting in                Commission will require divestiture of
                                             near future.                                            higher prices.                                        that product.
                                                Methylphenidate hydrochloride is a                      But for the proposed Consent                          Additionally, in mergers involving
                                             central nervous system stimulant used                   Agreement, the Proposed Acquisition                   complex pharmaceutical products that
                                             to treat attention-deficit disorder and                 also is likely to delay the introduction              are difficult to manufacture, the
                                             attention-deficit/hyperactivity disorder.               of beneficial competition, and                        Commission generally will require the
                                             Only four companies currently sell                      subsequent price decreases, by                        divestiture of an on-market product over
                                             generic methylphenidate hydrochloride                   eliminating future competition in seven               a pipeline product to place the greater
                                             ER tablets in the United States: Amneal,                markets in which either Amneal or                     risk on the merging parties rather than
                                             Mylan N.V., Teva, and Trigen Labs.                      Impax is a current competitor and the                 the public, with exceptions for
                                             Impax is one of only a limited number                   other is likely to enter. Multiple                    compelling and fact-specific reasons.
                                             of suppliers capable of entering the                    customers expressed concerns about the                When such compelling, fact-specific
                                             market for generic methylphenidate                      effect of the proposed merger on the                  reasons exist, ‘‘The goal of a divestiture
                                             hydrochloride ER tablets in the near                    market for generic aspirin and                        is to put the product development effort
                                             future.                                                 dipyridamole ER capsules, in which                    (including any pending regulatory
                                                Olopatadine hydrochloride nasal                      Amneal is the only current generic                    filings) in the hands of a new firm with
                                             spray is used to treat seasonal allergies.              competitor and Impax is approved to                   the same ability and incentive to bring
                                             Generic olopatadine hydrochloride                       enter. Impax is one of only three                     the pipeline product to market.’’ 2
                                             nasal spray is sold in the United States                competitors providing generic azelastine                 The proposed Consent Agreement
                                             by Sandoz, Apotex, and Impax                            nasal spray, and the imminent entry of                conforms to this approach and remedies
                                             partnered with Perrigo. Amneal is one                   Amneal likely would allow customers to                the competitive concerns raised by the
                                             of very few suppliers capable of entering               negotiate more competitive prices and                 Proposed Acquisition in the generic
                                             the market in the near future.                          secure adequate supply. Impax is one of               azelastine nasal spray and generic
                                                                                                     very few well-positioned entrants in the              olopatadine hydrochloride nasal spray
                                             II. Entry
                                                                                                     market for generic diclofenac sodium                  markets by requiring Impax to return
                                                Entry into the ten markets at issue                  and misoprostol DR tablets, in which                  any rights and assets it has to its partner
                                             would not be timely, likely, or sufficient              Amneal is one of four current                         and ANDA-owner for these products,
                                             in magnitude, character, and scope to                   competitors, and customers note that                  Perrigo. The proposed Consent
                                             deter or counteract the anticompetitive                 they would benefit from additional                    Agreement remedies the competitive
                                             effects of the Proposed Acquisition. The                entry to negotiate pricing. Amneal is the             concerns raised by the Proposed
                                             combination of drug development times                   only generic erythromycin tablet                      Acquisition in the generic fluocinonide-
                                             and regulatory requirements, including                  competitor, and Impax is one of a                     E cream market by requiring Impax to
                                             approval by the FDA, is costly and                      limited number of companies with                      return any rights and assets it has to its
                                             lengthy.                                                products in development that upon                     partner and ANDA-owner for this
                                             III. Competitive Effects                                entry would allow customers to                        product, G&W. The parties must
                                                                                                     negotiate lower prices. Amneal is the                 accomplish these divestitures no later
                                                The Proposed Acquisition likely                      only foreseeable entrant in the market                than ten days after they consummate the
                                             would cause significant anticompetitive                 for generic fluocinonide-E cream, in                  Proposed Acquisition.
                                             harm to consumers by eliminating                        which Impax is one of only three                         The proposed Consent Agreement
                                             current competition between Amneal                      competitors. In the market for generic                remedies the competitive concerns
                                             and Impax in the markets for generic                    methylphenidate hydrochloride ER                      raised by the Proposed Acquisition in
                                             desipramine hydrochloride tablets,                      tablets, Amneal is one of four current                seven of the markets at issue by
                                             generic ezetimibe and simvastatin IR                    competitors and Impax is one of few                   requiring Impax to divest all of its rights
                                             tablets, and generic felbamate tablets.                 potential entrants. Finally, Amneal is                and assets related to those products to
                                             Generic desipramine hydrochloride                       one of only a few entrants poised to                  ANI. ANI is a pharmaceutical
                                             tablets, generic ezetimibe and                          enter the market for generic olopatadine              corporation that develops,
                                             simvastatin IR tablets, and generic                     hydrochloride nasal spray, in which                   manufacturers, sells, and distributes
                                             felbamate tablets are commodity                         Impax is one of only three current                    solid oral, liquid, and topical
                                             products, and prices typically are                      competitors. Absent a remedy, the                     pharmaceutical products in the United
                                             inversely correlated with the number of                 Proposed Acquisition likely would                     States. ANI’s track record in developing
                                             competitors in each market. As the                      cause U.S. consumers to pay higher
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                                             number of suppliers offering a                          prices for the aforementioned generic                   1 See The FTC’s Merger Remedies 2006–2012: A
                                             therapeutically equivalent drug                         products.                                             Report of the Bureaus of Competition and
                                             increases, the price for that drug                                                                            Economics (Jan. 2017) at 36–37, https://
                                             generally decreases due to the direct                   IV. The Consent Agreement                             www.ftc.gov/system/files/documents/reports/ftcs-
                                                                                                                                                           merger-remedies-2006-2012-report-bureaus-
                                             competition between the existing                          As the Commission explained in its                  competition-economics/p143100_ftc_merger_
                                             suppliers and each additional supplier.                 remedy review, The FTC’s Merger                       remedies_2006-2012.pdf.
                                             Customers also raise concerns about                     Remedies 2006–2012: A Report of the                     2 See The FTC’s Merger Remedies Study at 31.




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                                                                               Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices                                                  19767

                                             and bringing to market pipeline                         jeopardize the only generic product on                employees of the parties. Under the
                                             products suggests that the divested                     the market.                                           proposed Consent Agreement, the
                                             products will be placed in the hands of                    The FDA approved Amneal’s ANDA                     Commission also will appoint an
                                             a firm with the same ability and                        for generic methylphenidate                           Interim Monitor.
                                             incentive to bring the products to                      hydrochloride ER tablets in February                     The Commission’s goal in evaluating
                                             market. As explained below, the                         2018. Impax also has an approved                      possible purchasers of divested assets is
                                             Consent Agreement helps make that                       ANDA. Impax’s product is contract                     to maintain the competitive
                                             outcome more likely.                                    manufactured, but the contract                        environment that existed prior to the
                                                For two of the products that both                    manufacturer needs to resolve                         Proposed Acquisition. If the
                                             Amneal and Impax currently market,                      manufacturing issues before it can                    Commission determines that ANI,
                                             generic desipramine hydrochloride                       resume manufacturing the product. It                  Perrigo, and/or G&W are not acceptable
                                             tablets and felbamate tablets, Impax will               will be less risky for Impax to assign its            acquirers, or that the manner of the
                                             assign its contract manufacturing                       manufacturing contract to ANI than to                 divestitures is not acceptable, the
                                             agreements to ANI. For the third                        affect a technology transfer from                     proposed Order requires the parties to
                                             currently-marketed product, Amneal                      Amneal for this complex product, and it               unwind the sale of rights to ANI,
                                             will supply ANI with generic ezetimibe                  will put the product in ANI’s hands,                  Perrigo, and/or G&W and then divest the
                                             and simvastatin IR tablets for two years                which has the same ability and                        affected products to a Commission-
                                             with the option to extend for two                       incentive as Impax to bring                           approved acquirer within six months of
                                             additional years.                                       methylphenidate hydrochloride ER                      the date the Order becomes final. The
                                                In four overlap markets in which                     tablets to market. Thus, the proposed                 proposed Order further allows the
                                             Amneal has an on-market product and                     Order requires the divestiture of Impax’s             Commission to appoint a trustee in the
                                             Impax has a product in development,                     rights and assets to ANI.                             event the parties fail to divest the
                                             Impax will divest its rights and assets to                 For generic diclofenac sodium and                  products as required.
                                             ANI rather than requiring Amneal to                     misoprostol DR tablets, Amneal has an                    The purpose of this analysis is to
                                             divest its on-market, in-house                          on-market in-house manufactured                       facilitate public comment on the
                                             manufactured products. Each of these                    product, and Impax is partnered with                  proposed Consent Agreement, and it is
                                             product markets has specific facts that                 Micro Labs to commercialize a                         not intended to constitute an official
                                             warrant the divestiture of the Impax                    competing product. Impax holds only                   interpretation of the proposed Order or
                                             rights and assets rather than the Amneal                marketing rights to the product; Micro                to modify its terms in any way.
                                             product. Of note, three products—                       Labs is responsible for development and                 By direction of the Commission.
                                             generic aspirin and dipyridamole ER                     manufacturing. Impax will transfer its
                                                                                                                                                           Donald S. Clark,
                                             capsules, generic methylphenidate                       marketing agreement with Micro Labs to
                                                                                                                                                           Secretary.
                                             hydrochloride ER tablets, and generic                   ANI, and Micro Labs will manufacture
                                             diclofenac sodium and misoprostol DR                    the product for ANI for the current                   [FR Doc. 2018–09546 Filed 5–3–18; 8:45 am]
                                             tablets—are more complicated to                         contract term.                                        BILLING CODE 6750–01–P

                                             manufacture because they have                              For erythromycin tablets, Amneal
                                             extended or delayed release                             launched its product in March 2018,
                                             characteristics.                                        and only one other competitor, Arbor                  DEPARTMENT OF HEALTH AND
                                                For generic aspirin and dipyridamole                 Pharmaceuticals, is currently selling                 HUMAN SERVICES
                                             ER capsules, Amneal is the only                         erythromycin tablets. Amneal
                                             manufacturer with a product on the                      manufactures the erythromycin tablets                 Centers for Disease Control and
                                             market. Amneal manufactures this                        in-house. Impax is one of a few                       Prevention
                                             product in-house. Impax received FDA                    companies developing the product, and
                                             approval for its ANDA in 2017 and had                   once approved, it plans to outsource the              Board of Scientific Counselors,
                                             expected to use a third-party                           manufacturing. Here, the easier-to-                   National Center for Health Statistics
                                             manufacturer to launch its product.                     divest product is the Impax drug in                   (BSC, NCHS)
                                             That manufacturer experienced some                      development. Thus, Commission staff                   AGENCY: Centers for Disease Control and
                                             manufacturing difficulties and Impax                    considers it prudent to leave the in-                 Prevention (CDC), Department of Health
                                             had begun the process of developing the                 house Amneal-manufactured product                     and Human Services (HHS).
                                             means to produce the product at its own                 with the merged firm, an ongoing and                  ACTION: Notice of meeting.
                                             facilities. With the divestiture, ANI will              viable competitor to Arbor. Further,
                                             finalize the manufacturing process and                  Impax will transfer all of its assets                 SUMMARY:   In accordance with the
                                             expects to have the Impax drug on the                   related to its development of                         Federal Advisory Committee Act, the
                                             market soon. Nevertheless, should ANI                   erythromycin tablets to ANI, which has                Centers for Disease Control and
                                             be unable to market its own version of                  the same ability and incentive to bring               Prevention (CDC), announces the
                                             this product by October 1, 2019, ANI                    a competing third erythromycin tablet to              following meeting for the Board of
                                             has the option to source generic aspirin                market.                                               Scientific Counselors, National Center
                                             and dipyridamole ER capsules from                          The proposed Order also requires                   for Health Statistics (BSC, NCHS). This
                                             Amneal until ANI obtains the necessary                  Amneal to provide transitional services               meeting is open to the public; however,
                                             regulatory approvals or through March                   to ANI, Perrigo, and G&W to assist them               visitors must be processed in
                                             1, 2021, whichever date is earlier. This                in establishing their manufacturing                   accordance with established federal
                                             ensures that ANI will be able to market                 capabilities and securing all of the                  policies and procedures. For foreign
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                                             a competing product near the time                       necessary FDA approvals. These                        nationals or non-U.S. citizens, pre-
                                             Impax likely would have had the                         transitional services include technical               approval is required (please contact
                                             product on market, and provides the                     assistance to manufacture the ten                     Gwen Mustaf, 301–458–4500, glm4@
                                             incentive for ANI to manufacture and                    products at issue in substantially the                cdc.gov, or Charles Rothwell, (301) 458–
                                             market its own product. An alternative                  same manner and quality employed or                   4500, cjr4@cdc.gov at least 10 days in
                                             divestiture of the Amneal product                       achieved by Impax. It also includes                   advance for requirements). All visitors
                                             would involve more risk and could                       advice and training from knowledgeable                are required to present a valid form of


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Document Created: 2018-11-02 09:53:09
Document Modified: 2018-11-02 09:53:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionProposed Consent Agreement.
DatesComments must be received on or before May 29, 2018.
ContactKari Wallace (202-326-3085), Bureau of Competition, 600 Pennsylvania Avenue NW, Washington, DC 20580.
FR Citation83 FR 19764 

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