The FTC filed a complaint in federal district court alleging that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm with an agreement not to market an authorized generic – often called a “no-AG commitment” – as a form of reverse payment. The complaint, filed in the Eastern District of Pennsylvania, alleges that Endo paid the first generic companies that filed for FDA approval – Impax Laboratories, Inc. and Watson Laboratories, Inc. – to eliminate the risk of competition for Opana ER and Lidoderm, in violation of the Federal Trade Commission Act. Opana ER is an extendedrelease opioid used to relieve moderate to severe pain. Lidoderm is a topical patch used to relieve pain associated with post-herpetic neuralgia, a complication of shingles. The FTC is seeking a court judgment declaring that the defendants’ conduct violates the antitrust laws, ordering the companies to disgorge their ill-gotten gains, and permanently barring them from engaging in similar anticompetitive behavior in the future. Teikoko Pharma USA and Teikoku Seiyaku Co., Ltd. agreed to a stipulated order resolving FTC charges.
In November 2016, the FTC voluntarily dismissed the complaint in this action. On January 23, 2017, the FTC refiled charges related to the Lidoderm agreements in federal court in California (Federal Trade Commission vs. Allergan plc; Watson Laboratories, Inc., et al) and refiled charges related to the Opana ER agreement in a Part 3 administrative proceeding. (In re Impax Laboratories, Inc.)