Actavis, Takeda Battle Over Generic Colchicine

Actavis has filed an abbreviated new drug application (ANDA) with FDA seeking approval to market colchicine tablets USP, 0.6 mg. Actavis’ abbreviated new drug application (ANDA)  product is a generic version of Takeda’s Colcrys®, which is a prescription medicine used in adults to prevent and treat gout flares.

Takeda Pharmaceuticals USA, Inc.
filed suit against Actavis on February 27, 2014 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents, according to an Actavis press release. 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.

Source: Actavis


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