Opana Generic Delay Deal Triggers Another Class Action Lawsuit

Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo’s pain medication Opana ER.

The Pennsylvania Employees Benefit Trust Fund filed a complaint against the brand and generics drugmakers in the U.S. District Court for the Northern District of Illinois, alleging that the delayed launch of Opana ER (oxymorphone hydrochloride) forced it to pay supracompetitive prices on the brand version for its members.

The claims closely mirror ones made in a June lawsuit against Endo and Impax brought by the Rochester Drug Co-operative.

Both lawsuits charge that in 2010, Endo settled patent infringement litigation against Impax’s Paragraph IV ANDA against Opana ER with a deal to keep a generic version off the market for three more years. In exchange, the lawsuits allege, Endo agreed to pay Impax at least $112 million and as much as $142 million to hold off the generic launch.

Endo also promised not to compete with Impax by launching its own generic, the complaints allege.

Because Impax was the first to file against Opana, Endo was able to use its deal as a bottleneck against other ANDAs from generics makers Roxane, Actavis and Sandoz, the complaints say.

Endo took full advantage of the delay, getting a revised, more crush-resistant version of the drug, Opana ER CRF, approved by the FDA, the complaints continue. The drugmaker used the three year delay from its alleged 2010 deal with Impax until the 2013 generic launch to replace batches of Opana ER on the market with Opana ER CRF. That, in turn, further delayed generics competition by effectively neutralizing ANDAs that were not deemed by the FDA to be substitutable with the new version, the complaints say.

Impax declined to comment for this article. Endo did not respond to a request to weigh in 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.