Actavis files ANDA to market Budesonide Extended-release Tablets

Feb 25 2015

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 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 February 17, 2015 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.

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.

For the 12 months ending December 31, 2014, Uceris^® had total U.S. sales of approximately $123 million, according to IMS Health data.