Endo facing second pay-for-delay lawsuit from FTC on Opana ER
On January 25, 2021, the U.S. Federal Trade Commission (“FTC”) filed a lawsuit alleging that Endo entered into a second anticompetitive agreement with Impax in 2017 designed to prevent competition for Opana ER. The FTC had previously sued alleging that a 2010 agreement entered into by Endo and Impax concerning the same product was anticompetitive. Endo settled that earlier matter while Impax continues to litigate it before the United States Court of Appeals for the Fifth Circuit.
This newest action brought by the FTC similarly involves Opana ER, an extended-release formulation of oxymorphone, an opioid used to treat moderate to severe pain. Endo’s Opana ER product generated nearly $160 million in revenues in 2016 alone. Endo removed a reformulated version of the product from the market in 2017 at the U.S. Food and Drug Administration’s request because the reformulated drug had a high risk of increased intravenous abuse.
The withdrawal of Endo’s Opana ER left Impax’s generic version of the original formulation of Opana ER as the only available extended-release oxymorphone drug on the market. The FTC alleges that in 2017 Endo entered into an agreement with Impax to receive a share of Impax’s monopoly profits in exchange for agreeing not to launch a competing product. This allowed Impax to maintain monopoly power in the market for FDA-approved oxymorphone extended release tablets. As a result, patients have been denied the benefits of competition, forcing them and other purchasers to pay millions of dollars a more a year for this medication.
This is not the first time that there have been allegations that Endo and Impax have entered into an illegal pay-for-delay agreement. In 2010, Endo and Impax entered into an agreement to settle a patent infringement lawsuit brought by Endo after Impax had submitted its application to market a generic version of Opana ER. AB-rated generics typically take 80% or more of the sales of a drug molecule from the brand name product within six months of generic entry. To prevent competition, Endo paid Impax to delay launching its generic version of Opana ER until January 2013. The FTC sued Endo and Impax alleging that this 2010 Agreement violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Opana ER.
The 2017 Agreement was entered into during the pendency of the FTC’s litigation over the 2010 Agreement and was made in connection with settlement of a breach of contract action between Endo and Impax. The FTC alleges that the 2017 Agreement eliminates any competition by Endo and that this lack of competition allows Impax to charges supracompetitive prices for its monopolized oxymorphone ER drug.
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