Actavis confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market buprenorphine transdermal system, 5 mcg/hr, 10 mcg/hr and 20 mcg/hr.
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 US District Court for the District of Delaware seeking to prevent Actavis from commercialising its ANDA product prior to the expiration of certain US 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 US sales of approximately $158 million, according to IMS Health data.