Actavis plc has filed an abbreviated new drug application (ANDA) with FDA seeking approval to market dronedarone hydrochloride tablets 400 mg. Actavis’ ANDA product is a generic version of Sanofi’s Multaq^®, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.

Sanofi and Sanofi-Aventis U.S. LLC filed suit against Actavis on February 26, 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 US patents, according to an Actavis press release. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA until Jan. 1, 2017, or 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 Multaq^® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Source: Actavis