Actavis plc, a global, integrated specialty pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the US 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 USA, Inc. filed suit against Actavis on February 27, 2014 in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain US 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 US sales of approximately $629 million, according to IMS Health data.
Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.