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Appeals court upholds Vyvanse exclusivity

November 11, 2010 1:57 AM UTC

The U.S. Court of Appeals for the District of Columbia Circuit upheld FDA's granting of five years of new chemical entity (NCE) exclusivity for ADHD drug Vyvanse lisdexamfetamine from Shire plc (LSE:SHP; NASDAQ:SHPGY). The court affirmed a decision from the U.S. District Court for the District of Columbia, which ruled in March that FDA reasonably interpreted the Food, Drug and Cosmetic Act in assigning NCE exclusivity to Vyvanse, and was correct in refusing to file an ANDA for a generic version of the drug from Actavis Group (Hafnarfjordur, Iceland). The exclusivity period for Vyvanse expires on Feb. 23, 2012. At Sept. 30, Shire reported nine-month revenue of $453.6 million for Vyvanse. ...