Actavis files ANDA with FDA to market Colchicine Tablets USP

Mar 3 2014

Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Colchicine Tablets USP, 0.6 mg.  Actavis' 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 U.S.A., 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.  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.

For the 12 months ending December 31, 2013, Colcrys^® had total U.S. sales of approximately $629 million, according to IMS Health data.