Impax Sues FTC Over Opana ER Settlement Dispute

Impax Laboratories has sued the Federal Trade Commission for improperly deciding that it’s 2010 settlement with Endo Pharmaceuticals over Opana ER (oxycodone extended release) was anticompetitive.

Impax and Endo agreed in May 2010 to settle patent litigation over Impax’s generic version of the drug, under which Impax was licensed to begin selling its generic in January 2013. In return, Endo agreed not to launch an authorized generic in exchange for a royalty, and to pay Impax an “Endo Credit” if its Opana ER sales fell by a certain amount before Impax launched its generic.

In 2017, the FTC found that the agreement was anticompetitive because the provisions transferred value from Endo to Impax by ensuring that Impax would be the only company selling oxymorphone ER for its first 180 days on the market.

The generic drugmaker claimed that the industry has long used reversed payments for patents settlements, and that the Supreme Court has determined that the FTC should use the “rule of reason” to determine if they are anticompetitive.