Actavis confirms patent challenge for generic Butrans

DUBLIN — Actavis on Friday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine transdermal system, a generic version of Butrans from Purdue Pharma. The drug is used for the treatment of severe pain. 

 

Purdue Pharma filed suit against the company on Sept. 24 to prevent it from commercializing the product before the expiration of certain U.S. patents. Actavis believes it may be a "first applicant" to file an ANDA for generic Butrans. If its ANDA is approved, the company may be entitled to 180 days of marketing exclusivity. 

 

Butrans had U.S. sales of $158 million for the 12 months ending July 31, according to IMS Health data.