Impax Pay-for-Delay Ruling Could Jump-Start FTC Enforcement

Watch your calendars for May 18.

That’s the date by which a Federal Trade Commission administrative law judge says he’ll issue his ruling in a pay-for-delay case involving allegations generic drugmaker Impax Laboratories Inc. accepted more than $100 million to delay its release of a generic version of Endo Pharmaceuticals Inc.’s opioid pain medication, Opana ER.

The ALJ’s ruling could potentially jump-start more FTC enforcement actions against drug companies for anticompetitive conduct.

The Impax case is the FTC’s latest effort to crack down on “pay-for-delay” or “reverse payment” deals in which brand-name drugmakers pay their generic competitors to keep cheaper alternatives off the market for a period of time.

And the ruling could help shed light on unsettled areas of antitrust law, including what constitutes a “large payment” that would violate antitrust laws.

Other than a pharmaceutical antitrust action brought by private party litigants over a reverse payment deal over the drug Nexium, the Impax case is the only other reverse payment case that’s gone to trial since 2017.

Meanwhile, the FTC will require Impax to divest its rights and assets to 10 generic drug products as a condition for drugmaker Amneal Pharmaceuticals LLC’s acquiring a $1.45 billion equity stake in Impax.

Read my article here.

Stay on top of new developments in health law and regulation, and learn more, by signing up for a free trial to Bloomberg Law.