Endo and Impax Face Another Pay-for-Delay Lawsuit Over Generic Opana ER

Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER.

The International Union of Operating Engineers Local 138 Welfare Fund asked an Illinois federal judge last week for class action status in an antitrust suit that claims Endo paid Impax at least $112 million, and as much as $142 million, in exchange for holding off on a generic launch for two-and-a-half years.

As a result of this action, the fund was forced to overpay for the brand version even though a cheaper generic would have hit the market much sooner if not for the deal, according to the Oct. 3 complaint. 

Impax was the first ANDA filer against Opana ER, meaning Endo was able to use its settlement deal as a bottleneck holding off approval of other generics, the complaint contends. In the interim, the fund says that Endo sought to shift patients to a newer crush-resistant formulation of the drug, Opana ER CRF, to further slow generic entry by forcing would-be competitors to submit brand-new ANDAs. 

The litigation follows two other lawsuits with the same complaints filed in June and August. Neither Endo nor Impax responded to requests for comment by press time. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.