Federal Judge Rules Actavis Must Remove Opana from Market

Actavis must remove its generic version of Endo’s noncrush-resistant painkiller Opana from the U.S. market by Oct. 13, a New York federal judge ruled Friday, citing infringement of Opana’s patents.

Judge Thomas Griesa’s order also prevents other companies from launching Opana ER (oxymorphone hydrochloride) any time soon. The ’122 and ’216 patents expire on Feb. 4, 2023, according to the FDA’s Orange Book.

The judge withheld deciding whether to award additional relief, including damages against Actavis, pending further briefing from Endo and Actavis.

The order was filed in Endo Pharmaceuticals Inc. v. Actavis Inc.et al., but affects other cases involving the ’122 and ’216 patents.

Four of those suits were previously dismissed — Par Pharmaceuticals and Mallinckrodt under settlements with Endo and Teva and Sandoz after the firms said they didn’t intend to pursue ANDAs of Opana. Endo also had sued Roxane and Ranbaxy over their plans to file ANDAs. All were filed in 2013 in the U.S. District Court for the Southern District of New York, the same court where Endo sued Actavis in December 2012.

Details of the judge’s decision contain confidential material and are under seal. — Jonathon Shacat