Actavis Confirms Generic Uceris Patent Challenge

Actavis has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market Budesonide Extended-Release Tablets, 9 mg.  Actavis' ANDA product is a generic version of Salix Pharmaceuticals' Uceris®, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Cosmo Technologies Limited and Santarus, Inc. filed suit against Actavis on 17 February 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 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.

Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Uceris and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.