Actavis files ANDA for generic of Purdue's Butrans

Ireland-headquartered generics major Actavis (NYSE: ACT) has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market its Buprenorphine Transdermal System, a generic version of privately-held Purdue Pharma’s Butrans. It is indicated for the management of severe pain requiring daily, round-the-clock long-term opioid treatment for which alternative treatment options are inadequate.

Purdue filed suit against Actavis on September 24 in the US District Court of Delaware to stop Actavis from commercializing the ANDA product prior to certain patents on Butrans expiring. The law suit 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.

Butrans had total US sales of around $158 million for the 12 months ending July 31, according to IMS Health data. Actavis believes it may be a ‘first applicant’ to file an ANDA for a generic of the drug, and if it is approved, the company may be entitled to 180 days of generic market exclusivity.