Actavis Confirms Generic Zubsolv Patent Challenge - Quick Facts

(RTTNews) - Actavis Plc (ACT) confirmed filing an Abbreviated New Drug Application or ANDA with the U.S. Food and Drug Administration or FDA, seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Orexo AB and Orexo US, Inc. have filed lawsuit against Actavis on June 26, 2014, in the U.S. District Court for the District of Delaware to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents. The litigation was filed as per 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.

Actavis believes that it may be a "first applicant" to file an ANDA for the generic version of Zubsolv and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.