Tag: Prescription Drugs

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.

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.

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.