It’s looking like there won’t be any more generic, crush-resistant versions of Endo Pharmaceuticals Inc.’s opioid painkiller Opana ER on the market for a while.
And a recent court ruling upholding the validity of a patent covering Opana ER is likely to keep proposed generic crush-proof versions made by Teva Pharmaceuticals USA Inc. and Amneal Pharmaceuticals LLC off the market until late 2029. That’s when Mallinckrodt LLC’s patent on the drug expires.
Opioid analgesics like Opana ER can be highly addictive and the crush-resistant formulation of the painkiller is designed to make the product more difficult to abuse and misuse. The crush-resistant feature is becoming more important to the market as public concern grows about the increasing incidence of opioid abuse in the U.S.
Four years ago, Endo withdrew its original formula of Opana ER from the market and replaced it with Opana ER CRF (crush-resistant formulation).
Currently, Impax Laboratories Inc. makes the only generic version of the crush-resistant version of Opana ER on the market, an authorized generic version that it started marketing in January 2013.
Based on the latest court ruling, it looks like things are going to stay that way for some time to come.
A copy of the court’s Oct. 7 ruling is at http://src.bna.com/jix.
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