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PARSIPPANY, N.J. — Actavis Inc. has entered into an agreement with Purdue Pharma to settle all outstanding patent litigation related to Actavis’ generic version of the abuse-deterrent formulation of OxyContin.
Actavis said Friday that under the settlement, it will be licensed to market a specified number of bottles of its generic OxyContin (oxycodone) starting on Jan. 1, 2014. The launch of Actavis’ product depends on the company receiving Food and Drug Administration approval of its Abbreviated New Drug Application (ANDA) for generic OxyContin.
If Actavis doesn’t gain FDA approval of its generic OxyContin before Sept. 1, 2014, the company will be permitted to launch a specified number of bottles of an authorized generic version of Purdue’s abuse-deterrent product beginning in October 2014, according to Actavis.
"The agreement provides a date-certain launch that eliminates the risk of current and future litigation related to all versions of OxyContin," stated Paul Bisaro, president and chief executive officer of Actavis. "It also eliminates the uncertainty surrounding FDA review and approval of generic versions of abuse deterrent products. Consumers and Actavis shareholders will now benefit from the distribution of product beginning in 2014."
OxyContin, an opioid pain reliever, had U.S. sales of about $2.8 billion for the 12 months ended January 31, according to IMS Health figures reported by Actavis.
