FTC rules Impax received illegal payments to block pain reliever generic

Pharmaceutical company Impax Laboratories engaged in illegal pay-for-delay settlements to stop a generic version of one of Endo Pharmaceutical's medications from entering the market, the US Federal Trade Commission has ruled.

In a statement on March 29, the FTC said Impax had blocked consumer access to a lower-cost version of Endo Pharmacetuical’s branded opioid pain-reliever Opana ER (oxymorphone).

The FTC found Endo, which possesses market power for branded and generic oxymorphone, paid Impax a “large and unjustified payment” and promised not to launch a generic during the 180-day exclusivity period that the Hatch-Waxman Act provides to the first generic filer.

The agreement also said that Endo would make a payment to Impax in the event that the market for Opana ER declined before Impax’s entry date.

In its conclusion, the FTC cited an earlier decision from the US Supreme Court in a separate case, which held that “eliminating the risk of competition through a reverse payment settlement itself constitutes an anticompetitive harm”.

The FTC said there was “ample evidence that Impax could have launched a generic product before the agreed-upon date, had it not entered into the reverse payment settlement with Endo”.

It said Impax had filed to show a “procompetitive rationale” for its pay-for-delay agreement, and barred Impax from entering into any future agreements that restrict generic entry within 45 days of a patent settlement.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.