Actavis to sell generic reformulated OxyContin in 2014

Actavis will be able to sell defined quantities of a generic version or an authorized generic version of reformulated OxyContin as early as next year, according to Purdue Pharma L.P., the manufacturer of the opioid analgesic.

Purdue and Actavis have settled patent infringement lawsuits that included patents for its abuse-deterrent reformulated OxyContin (oxycodone HCl controlled-release) Tablets CII.

This announcement came 10 days after FDA’s announcement that the Agency would not approve any generic versions of the original OxyContin formulation, as the benefits no longer outweighed the risks. FDA also approved updated labeling for reformulated OxyContin, indicating that the product has physical and chemical properties that are expected to make misuse and abuse via injection difficult and to reduce abuse via the intranasal route.

"Today's agreement [between Purdue and Actavis] will promote competition and allow for availability of generic formulations of reformulated OxyContin.  At the same time, this resolution relieves us of the risks, distractions and costs of continued litigation. We are pleased that this matter has been resolved in a manner that respects the inventions we have incorporated into the reformulated OxyContin tablets," said John H. Stewart, president and CEO of Purdue.