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DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.
The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.
The filing contained a paragraph IV certification, a legal challenge to a patent on the drug, triggering a lawsuit against Actavis that Dow and Valeant filed in the U.S. District Court for the District of New Jersey last week. Under the Hatch-Waxman Act of 1984, the lawsuit places a 30-month stay of FDA approval on Actavis' product, unless the companies settle the case. As the first company to successfully file for FDA approval, Actavis would be entitled to 180 days of market exclusivity in which to market the direct in direct competition against the branded version.
Acanya had sales of $62 million during the 12-month period that ended in July, according to IMS Health.