Opana Antitrust Suit Sent Back After Class Status Appeal

Endo and Impax, which face antitrust litigation for allegedly delaying generic versions of the prescription painkiller Opana ER, tentatively won their bid to have a federal appeals court in Chicago overturn a ruling designating the case a class action.

The US Court of Appeals for the Seventh Circuit sent the case back to Judge Harry D. Leinenweber, directing him either to carve out two groups of categorically unharmed Opana buyers from the class definition or explain why they “were not a barrier to certification” of the class action.

According to the complaint, Endo’s Opana ER (oxymorphone extended release) product, a long-acting opioid indicated for the treatment of moderate to severe pain, generated nearly $160 million in revenues in 2016 alone. In June 2017, the FDA asked Endo to voluntarily withdraw its drug from the market because of safety concerns about the reformulated version of Opana ER that Endo launched in 2012. The FDA’s safety concerns were informed by data indicating that Endo’s reformulated Opana ER resulted in increased intravenous abuse, according to the complaint. The withdrawal of Endo’s drug left Impax’s generic version of the original formulation of Opana ER as the only extended-release oxymorphone drug on the market.

After deciding to withdraw its reformulated Opana ER, Endo explored bringing another oxymorphone ER drug to the market or partnering with a third-party generic company as a way to replace its Opana ER revenues. But ultimately, the FTC alleges, Endo reached an agreement in August 2017 with Impax, the only other authorized seller of an oxymorphone ER product. The agreement eliminated potential competition from Endo by sharing Impax’s monopoly profits, with Endo in the role of a potential entrant paid to stay out of the market. This agreement allowed Impax to exercise and maintain monopoly power in the market for FDA-approved oxymorphone ER tablets, according to the complaint.

The 2017 agreement between Endo and Impax arose 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. 

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