The Federal Trade Commission (FTC) has filed suit against Endo Pharmaceuticals, Inc., Endo International plc (together, Endo), Impax Laboratories, LLC, and Impax’s parent company, Amneal Pharmaceuticals, Inc. (together, Impax), alleging that a 2017 agreement between Endo and Impax violated the antitrust laws by jettisoning competition in the market for the drug oxymorphone extended-release (ER).
The Jan. 25 complaint, the public version of which was not available at the time of this writing, accuses the defendants of violating the Sherman and FTC Acts. According to the FTC’s press release, the heart of the illegal conduct centers around Endo’s agreement to stay out of the market in exchange for a cut of Impax’s monopoly profits.
Endo and Impax’s August 2017 agreement allegedly stemmed from “a breach of contract case relating to a 2010 patent settlement between the companies over Impax’s generic of the original version of Opana ER, in which Endo paid Impax more than $112 million not to compete.” The press release explains that the FTC objected to the 2010 agreement and filed suit against the parties in January 2017.
In 2019, the Commission ruled that Impax indeed engaged in an illegal pay-for-delay settlement to block consumers’ access to a lower-cost generic version of Endo’s branded extended-release opioid pain killer. The FTC’s decision is currently being appealed.
This week’s FTC complaint claims that Endo’s oxymorphone ER product, a long-acting opioid used to treat moderate to severe pain, generated nearly $160 million in revenue in 2016 alone. Citing concerns over intravenous abuse of the extended-release version, the U.S. Food and Drug Administration requested that Endo take it off the market in June 2017, which it did. Reportedly, the hole left by Endo’s drug made Impax’s generic oxymorphone ER drug the only one on the market.
Though Endo contemplated developing another oxymorphone ER drug, it instead reportedly reached an understanding with Impax in August 2017. The FTC alleges that the parties agreed that Endo would stay out of the market in exchange for a share of Impax’s profits, thereby allowing Impax to exercise and maintain monopoly power in the market for oxymorphone ER.
The complaint reportedly seeks monetary and injunctive relief “to undo the ongoing competitive effects from this agreement,” and a permanent injunction prohibiting Endo, Impax, and Amneal from engaging in similar conduct. The press release also notes that the FTC’s vote to file the complaint was 3-2, with Commissioners Noah Joshua Phillips and Christine S. Wilson voting “no.”