Actavis seeks approval for testosterone-replacement gel

PARSIPPANY, N.J. — Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

Actavis, formerly known as Watson Pharmaceuticals, said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Endo Pharmaceuticals' Fortesta (testosterone) gel in the 10 mg-per-0.5 g strength.

Endo and partnering company Strakan International filed suit against Actavis in the U.S. district Court for the Eastern District of Texas Marshall Division seeking to prevent Actavis from launching its product. The lawsuit puts an automatic stay of FDA approval on the drug for up to 30 months or until the companies settle the suit. Actavis said it was likely the first company to file an approval application with the FDA for the drug, which would entitle it to 180 days' of market exclusivity in which to compete directly with the branded version following FDA approval.

Fortesta had sales of about $50 million in 2012, according to IMS Health.