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FDA approves first generic Copaxone

April 17, 2015 1:06 AM UTC

FDA approved once-daily Glatopa glatiramer acetate from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) to treat relapsing forms of multiple sclerosis (MS). Glatopa is the first FDA-approved generic version of Copaxone from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).

In January, the U.S. Supreme Court overturned an appeals court decision that invalidated the last U.S. patent for once-daily Copaxone and remanded the case to the U.S. Court of Appeals for the Federal Circuit (CAFC). A decision by CAFC is pending; Sandoz declined to comment on whether it would launch at risk prior to the expiration of Teva's patent on Sept. 1, 2015. Sandoz also declined to disclose Glatopa's price (see BioCentury Extra, Jan. 20). ...