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ANI/Novitium, In the Matter of
The Federal Trade Commission required generic drug marketers ANI Pharmaceuticals, Inc. and Novitium Pharma LLC to divest, to Prasco LLC, ANI’s development rights to one generic drug and assets with respect to another generic drug as part of a settlement resolving charges that ANI’s $210 million acquisition of Novitium likely would be anticompetitive. According to the complaint, without a remedy, the acquisition would likely harm future competition in U.S. markets for both of these generic products. The order requires ANI and Novitium to divest ANI’s rights and assets to generic SMX-TMP oral suspension and generic dexamethasone tablets to Prasco within 10 days after the acquisition is final. On Jan. 12, 2022, the Commission announced the final consent order in this matter.
FTC, States to Recoup Millions in Relief for Victims Fleeced by ‘Pharma Bro’ Scheme to Illegally Monopolize Life-Saving Drug Daraprim
ANI/Novitium; Analysis of Agreement Containing Consent Orders To Aid Public Comment
Bristol-Myers Squibb Company and Celgene Corporation, In the Matter of
Pharmaceutical and biologic manufacturers Bristol-Myers Squibb Company and Celgene Corporation agreed to divest Celgene’s Otezla, the most popular oral treatment in the United States for moderate-to-severe psoriasis, for $13.4 billion. The divestiture settled Federal Trade Commission charges that BMS’s proposed $74 billion acquisition of Celgene would violate federal antitrust law. Under the terms of the proposed consent order, the parties were required to divest Celgene’s worldwide Otezla business – including its regulatory approvals, intellectual property, contracts, and inventory – to Amgen, Inc. no later than 10 days after consummating the proposed acquisition. On Nov. 12, 2021, the Commission announced that it has approved certain modifications to Bristol Meyers Squibb’s divestiture agreements.
16 CFR Part 1, Subpart S: Procedures for Submission of Rules under the Horseracing Integrity and Safety Act
FTC Staff Opinion with Respect to Doylestown Health Physicians
Federal Trade Commission Withdraws Remaining Case against AbbVie after Supreme Court Decision Strips Consumers of Relief
AbbVie Inc., et al.
The FTC filed a complaint in federal district court in September 2014 charging that AbbVie Inc. and its partner Besins Healthcare Inc. illegally blocking American consumers’ access to lower-cost alternatives to Androgel by filing baseless patent infringement lawsuits against potential generic competitors. In a June 2018 decision, the U.S. District Court for the Eastern District of Pennsylvania ruled that AbbVie used sham litigation to illegally maintain its monopoly over the testosterone replacement drug Androgel, and ordered $448 million in monetary relief to consumers who were overcharged for Androgel as a result of AbbVie’s conduct.
In September 2020, the Third Circuit affirmed the district court’s finding of liability on the FTC’s sham litigation claim, and reinstated the reverse payment claim, two important legal victories that protect competition in pharmaceutical markets.
While handing the Commission important legal victories, the Third Circuit reversed the district court’s nearly half-billion dollar monetary judgment for consumers, holding that the FTC is not entitled to disgorgement under 13(b) of the FTC Act. This determination was effectively affirmed by the Supreme Court’s decision in AMG Capital Management v. FTC.
Since the initial filing of the lawsuit, generic AndroGel products have entered the market, so that patients now benefit from competition among multiple suppliers. AbbVie and Teva are also now subject to Commission orders preventing them from entering into certain reverse-payment settlements. On July 30, 2021, the Commission announced that it has withdrawn its reverse-payment claim from federal district court, ending its litigation against AbbVie.
Statement of Commissioners Noah Joshua Phillips and Christine S. Wilson regarding the Multilateral Pharmaceutical Merger Task Force
Multilateral Pharmaceutical Merger Task Force Seeks Public Input
FTC Returns Nearly $60 Million to Those Suffering from Opioid Addiction Who Were Allegedly Overcharged in Suboxone Film Scheme
U.S. Court of Appeals for the Fifth Circuit Upholds FTC’s Opinion against Generic Pharmaceutical Company Impax Laboratories, LLC
Impax Laboratories, Inc., In the Matter of
The FTC's administrative complaint against Impax charges that in 2010, Impax and Endo Pharmaceuticals Inc. illegally agreed that Impax would not compete by marketing a generic version of Endo’s Opana ER until January 2013. In exchange, Endo paid Impax more than $112 million.
Endo agreed to settle these charges in a stipulated order entered in federal court. See FTC v. Allergan plc, and Watson Laboratories, Inc. et al.
The Commission’s 2019 opinion held that the FTC staff had proven that the agreement between Impax and Endo Pharmaceuticals Inc. violated Section 5 of the Federal Trade Commission Act. The Commission’s opinion reversed Chief Administrative Law Judge D. Michael Chappell’s initial decision.
In April 2021, the U.S. Court of Appeals for the Fifth Circuit upheld the Commission’s opinion.
FTC Announces Multilateral Working Group to Build a New Approach to Pharmaceutical Mergers
Endo Pharmaceuticals Inc./Amneal Pharmaceuticals, Inc.
The FTC is suing Endo Pharmaceuticals, Inc., Endo International plc, Impax Laboratories, LLC, and Impax’s owner, Amneal Pharmaceuticals, Inc., alleging that a 2017 agreement between Endo and Impax violated the antitrust laws by eliminating competition in the market for oxymorphone ER. The complaint charges the defendants with violating Sections 1 and 2 of the Sherman Act, which constitutes unfair methods of competition in violation of Section 5 of the FTC Act. Specifically, Endo, Impax, and Amneal are charged with entering into an illegal agreement in restraint of trade, and Amneal is charged with monopolization of the oxymorphone ER market. The complaint was filed in the U.S. District Court for the District of Columbia on Jan. 25, 2021.
FTC Again Charges Endo and Impax with Illegally Preventing Competition in U.S. Market for Oxymorphone ER
Pfizer Inc. and Mylan N.V.; Analysis of Agreement Containing Consent Orders To Aid Public Comment
Statement of Commissioner Christine S. Wilson in the Matter of Pfizer Inc./Mylan N.V.
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