Patent Expiration May Not Help OxyContin Generics
OxyContin’s method of treatment patent expires April 16, but several patents remain tied up in litigation over APIs as Purdue and generic companies await FDA decision on whether the original formulation can be a reference product.
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Generic manufacturer could begin selling either its own product or an authorized generic of the controlled-release opioid as early as Jan. 1, 2016.
Purdue Pharma is looking for assistance from FDA to help protect the company’s OxyContin franchise from both branded and generic competitors.
Two years ago, Purdue Pharma's lawyers anxiously gathered together on a conference call. The U.S. Court of Appeals for the Federal Circuit had just issued its second opinion in OxyContin patent litigation. But the court's earlier ruling had accidentally been posted online. For a tense 20 minutes they waited until one of Purdue's outside attorneys got the final decision