FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FTC Rules Impax Broke Law With Reverse Payment Deal for Endo Opioid

April 9, 2019

Generics maker Impax is barred from signing any reverse payment agreements under a new order by the Federal Trade Commission that determined the company broke the law when it signed a deal with Endo Pharmaceuticals to keep a generic opioid off the market.

The commission ruled that Impax’ reverse payment agreement with Endo over Endo’s Opana ER opioid violated federal trade laws. The U.S. Supreme Court recently ruled that eliminating the risk of competition should be considered monopolistic and the FTC found that “there was ample evidence” of such a risk in the Impax-Endo agreement.

The commission’s decision comes nearly a year after an administrative law judge tossed out the FTC’s lawsuit challenging the agreement, ruling that the commission’s complaint was “largely theoretical.”

Impax has 60 days to appeal the order.

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