Hyderabad, March 5 (PTI): French drug-maker Sanofi has filed a patent infringement petition against Glenmark on cardiac drug Multaq in the US district court of Delaware on three counts.
According to the petition, the Indian drug maker had submitted its application to seek the US Food and Drug Administration’s (USFDA) approval for its generic version of the drug on January 24.
Sanofi and Sanofi-Aventis US LLC filed the suit against Glenmark and Dublin-based Actavis (Watson) on February 26 in the US court seeking to prevent the duo from commercialising its ANDA product prior to the expiration of certain US patents. The lawsuit was filed under the provisions of the Hatch-Waxman act.
Multaq is an anti-arrhythmic drug indicated to reduce the risk of hospitalisation for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
For the 12 months ending December 31, 2013, Multaq had total US sales of approximately $319 million, according to IMS Health data.
Actavis in its statement claimed that it might get the first filer advantage. “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, it may be entitled to 180 days of generic market exclusivity.”