Actavis challenges Multaq and Colcrys patents

2 March 2014

Ireland-headquartered generic drugmaker Actavis (NYSE: ACT) revealed on Friday (February 28) that French pharma giant Sanofi (Euronext: SAN) had filed suit on February 26, in the US District Court for the District of Delaware, seeking to prevent Actavis from commercializing its Abbreviated New Drug Application for a generic version of Multaq (dronedarone) prior to the expiry of certain US patents.

Actavis also confirmed that it has filed an ANDA with the US Food and Drug Administration seeking approval to market dronedarone hydrochloride tablets 400mg, 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.

Law suit means final stay of FDA approval until January 2017

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