Teva set to lose Copaxone exclusivity in 2014

An appeals court ruling on Friday means Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) will lose exclusivity for multiple sclerosis (MS) drug Copaxone glatiramer acetate on May 24, 2014, more than a year sooner than the company had previously expected. The U.S. Court of Appeals for the Federal Circuit invalidated a process patent held by Teva covering Copaxone that was set to expire on Sept. 1, 2015. Teva, which recorded U.S. Copaxone sales of $806 million in 1Q13 and $2.9 billion in 2012, said it plans to appeal the ruling.

Teva originally filed suit in 2008 alleging that ANDAs for generic versions of Copaxone submitted by Mylan Inc. (NASDAQ:MYL) and the Sandoz International GmbH generics unit of Novartis AG (NYSE:NVS; SIX:NOVN) infringed Teva's patents covering the drug. Mylan was appealing a 2012 decision in favor of Teva from the District Court for the Southern District of New York (see BioCentury Extra, June 25, 2012). ...