PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.
Under the settlement, Actavis will be able to market a limited quantity of its version of the drug, known generically as oxycodone extended-release tablets, starting on Jan. 1, 2014, pending Food and Drug Administration approval. If Actavis is unable to get approval from the FDA, it will be allowed to market an authorized generic version of the drug starting in October 2014; an authorized generic is a branded drug marketed under its generic name at a discount.
Actavis' generic, like the branded version marketed by Purdue, includes abuse-deterrent properties designed to make the drug less useful if it is crushed or dissolved. The announcement comes less than two weeks after the FDA announced that it would not approve any generic of the old version of OxyContin, which did not include abuse-deterrent features. Purdue withdrew that version of the drug in 2010.
"The agreement provides a date-certain launch that eliminates the risk of current and future litigation related to all versions of OxyContin," Actavis president and CEO Paul Bisaro said. "It also eliminates the uncertainty surrounding FDA review and approval of generic versions of abuse-deterrent products."
The FDA made its announcement amid fears expressed by public health officials, politicians and others that generic versions of OxyContin without abuse-deterrent features would encourage abuse. The drug has long been a target of drug abusers who crush the pills in order to snort or inject them. Still, it also raised concerns about whether a cheaper, generic version of OxyContin would become available to consumers.
OxyContin had sales of $2.8 billion during the 12-month period that ended in January, according to IMS Health.
"Today's agreement will promote competition and allow for availability of generic formulations of reformulated OxyContin," Purdue president and CEO John Stewart said. "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."
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