Actavis Confirms Generic Multaq Patent Challenge By Sanofi - Quick Facts

(RTTNews) - Specialty pharmaceutical company Actavis Plc. (ACT) said Friday that French drug maker Sanofi (SNYNF.PK, SNY) 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 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 until January 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Actavis also confirmed today that it has filed an Abbreviated New Drug Application or ANDA with the U.S. Food and Drug Administration or 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 or AF in patients in sinus rhythm with a history of paroxysmal or persistent AF.

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.

For the 12 months ending December 31, 2013, Multaq had total U.S. sales of about $319 million, according to IMS Health data.