Actavis has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (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, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence.
Orexo AB and Orexo US, Inc. filed suit against Actavis on June 26, 2014, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. 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 Zubsolv and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.