BioCentury
ARTICLE | Company News

Sun Pharmaceutical, Teva, Apotex, AstraZeneca, Aurobindo, Cobalt Laboratories Inc., Glenmark, Mylan, Novartis, Par Pharmaceutical, Torrent, Watson, Brigham and

December 24, 2012 8:00 AM UTC

The U.S. Court of Appeals for the Federal Circuit upheld a lower court decision finding that the U.S. substance patent covering AstraZeneca's cardiovascular drug Crestor rosuvastatin is valid and enforceable. In 2010, the U.S. District Court for the District of Delaware ruled in a consolidated case that ANDA submissions from eight generic manufacturers, including Novartis' generic unit Sandoz, infringed U.S. Patent No. RE 37,314, which covers the chemical compound rosuvastatin calcium. Under the appeals court ruling, none of the ANDAs may be approved prior to the expiration of the patent in 2016...