Actavis’ ANDA product is a generic version of Purdue Pharma’s Butrans, which is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
Purdue Pharma L.P. filed suit against Actavis on September 24, 2014 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Butrans® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending July 31, 2014, Butrans® had total U.S. sales of approximately $158 million, according to IMS Health data.