Actavis seeks approval for generic opioid-dependence drug

Reckitt Benckiser, MonoSol Rx sue generic drug maker

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

In response to the filing, Reckitt Benckiser Pharmaceuticals, a subsidiary, and MonoSol Rx filed suit against Actavis last week in the U.S. District Court for the District of Delaware, seeking to prevent Actavis from commercializing its product before the expiration of certain patents on Suboxone. According to FDA records, the patents covering Suboxone will expire in 2023 and 2030. Under the Hatch-Waxman Act of 1984, the lawsuit places a stay of final FDA approval on Actavis' product for 30 months, or until a settlement is reached.

Suboxone had sales of about $1.2 billion during the 12-month period that ended in August, according to IMS Health.


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