Actavis confirms generic Suboxone sublingual film patent challenge

US generics major Actavis (NYSE: ACT) has confirmed filing an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market buprenorphine hydrochloride and naloxone HCl sublingual film 2mg/0.5mg and 8mg/2mg, a generic version of Reckitt Benckiser's (LSE: RB) Suboxone sublingual film, which is indicated for maintenance treatment of opioid dependence.

Reckitt Benckiser Pharmaceuticals Inc, RB Pharmaceuticals Limited and MonoSol Rx filed suit against Actavis on October 8, 2013, in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of US 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.

Believed to be “first to file”