Actavis confirms generic Uceris patent challenge

Ireland-headquartered generics major Actavis (NYSE: ACT) yesterday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market budesonide extended-release tablets, 9mg.

Actavis' ANDA product is a generic version of Salix Pharmaceuticals' (Nasdaq: SLXP) Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Gastrointestinal specialist Salix (which is the patent holder for Uceris) is currently the subject of an around $10 billion acquisition by Canada’s Valeant Pharmaceutical International (TSX: VRX).

Cosmo Technologies (part of Salix) and Santarus (a subsidiary of Valeant) filed suit against Actavis on February 17, 2015 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 law suit 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.