FTC v. Endo: Does No-Authorized Generic Agreement Meet Supreme Court Pay-For-Delay Test?

FTC alleges Endo's Opana ER patent settlement with Impax gave it time to introduce a reformulated product; agency also challenges side deal on Parkinson's disease drug and Endo's Lidoderm settlement with Watson.

The Federal Trade Commission's pay-for-delay suit against Endo Pharmaceuticals Inc. over its settlements of Opana ER (oxymorphone) and Lidoderm (lidocaine) patent litigation is the agency's first case challenging agreements in which the brand name company promises not to market an authorized generic.

Private parties have sued pharma companies for no-AG agreements but it remains unclear whether such arrangements may constitute an antitrust violation under the Supreme Court's 2013 ruling in FTC v. Actavis. The FTC's March 30 complaint contends that Endo's agreements with Impax Laboratories Inc. to delay entry of a generic version of Opana ER and with Watson Laboratories Inc

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