Sanofi sues Actavis over generic version of heart drug Multaq

PARIS Fri Feb 28, 2014 12:28pm EST

PARIS Feb 28 (Reuters) - French pharmaceutical company Sanofi has filed a lawsuit against Actavis over alleged patent infringements on its heart drug Multaq, hindering the generic drugmaker's plans to produce its own version of the drug.

Multaq, also known as dronedarone, is prescribed in patients suffering from irregular heartbeat and the main patent on the drug is due to expire in July 2016. Multaq generated sales of 269 million euros ($368 million) last year, up 8.2 percent from 2012, according to Sanofi's website.

Actavis said in a statement on Friday it had filed an application with the Food and Drug Administration to have its generic version of Multaq approved in the United States, but that Sanofi had filed a suit on Wednesday in the U.S. District Court of Delaware.

The suit alleges infringement of three U.S. patents on Multaq, a Sanofi spokeswoman said, giving no further details.

The suit automatically triggered a stay of approval by the FDA, keeping the generic product off the U.S. market until Jan 1, 2017, or until the matter is solved in court, Actavis said.

The news comes just a month after Sanofi sued U.S company Eli Lilly for allegedly infringing several patents on its top-selling diabetes drug Lantus. The suit should keep Lilly's biosimilar version off U.S. shelves until mid-2016, more than a year later than its initially expected launch date.

Generic competition cut 1.25 billion euros from Sanofi's sales last year but the drugmaker has been overhauling its research in an effort to produce new, harder-to-copy biologic drugs in the coming years.

To read Actavis' statement: