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Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed the ruling of the U.S. District Court for the District of Columbia and the U.S. Food and Drug Administration to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire U.S. Inc. under the name VYVANSE®.
The five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE is further protected by United States patents, the first of which expires on June 29, 2023. As a result of this confirmation of VYVANSE’s NCE status, generic manufacturers cannot submit an ANDA to FDA until February 23, 2011 at the earliest.
