The Federal Trade Commission has been cracking down on “pay-for-delay" deals across pharma, and Impax Laboratories is the latest company to face a slapdown for violating competition law. The FTC concluded the company entered an illegal “pay-for-delay" deal with Endo to put off copies of opioid painkiller Opana ER.
The agency says Endo controlled the market for the pain drug and gave Impax a “large and unjustified payment” to deter generic competition. Under the deal, Endo agreed to pay Impax more if Opana's market shrank before the generic launch, the FTC said. Endo also agreed to hold off on its authorized generic during Impax's 180-day period of generic exclusivity. And the FTC said Impax couldn't reasonably justify the cash payment that changed hands.
The FTC previously alleged Endo paid Impax $112 million in 2010 to delay its generic until January 2013. In 2017, amid worries about Opana ER's potential for abuse, Endo pulled the drug off the market at the FDA's request.
Endo itself faced similar allegations over Opana ER and its pain relief patch Lidoderm; it agreed to settle with the FTC in 2017. In that settlement, Endo promised not to engage in future pay-for-delay deals for an undisclosed period of time. The FTC refiled its complaints against generic defendants.
Impax merged with Amneal in a $6.4 billion deal that wrapped up last year. The companies kept Amneal's moniker and now rank among the top five generics players.
On Friday, the FTC said it found “ample evidence” that Impax could’ve launched an Opana ER generic earlier if it hadn't made a deal with Endo. Under a final order issued by the agency, Impax can’t enter similar reverse payment agreements and can't make any agreements on oxymorphone ER. Impax has up to 60 days to appeal.
Aside from “pay-for-delay" scrutiny, Endo has pulled Opana ER from the market at the request of the FDA. Back in 2017, the agency said the drug’s risks outweighed its benefits amid a deadly opioid and addiction crisis. Endo formulated the med to deter abuse, but addicts still reportedly found ways to misuse it.