Actavis confirms patent challenge surrounding generic Zubsolv

DUBLIN — Actavis on Monday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets, a generic version of Zubsolv from Orexo.



Orexo filed suit against Actavis on June 26 to prevent Actavis from commerializing its ANDA product before the expiration of certain U.S. patents, the company said. Actavis believes it may be the first to file for generic version of Zubsolv, based on available information.