Watson confirms patent challenge over generic 5-ARI

Watson Laboratories has filed an abbreviated new drug application with the FDA seeking approval to market dutasteride capsules, 0.5 mg.

The product is a generic version of GlaxoSmithKline’s 5-alpha-reductase inhibitor Avodart, which is indicated for the treatment of symptomatic BPH.

Watson said GlaxoSmithKline LLC filed suit against Watson on June 17 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its dutasteride capsules product prior to the expiration of a U.S. patent.

GlaxoSmithKline’s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s application until Nov. 17, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities, a Watson statement said.