US Pharm. 2010;35(12):104.Shire plc announced that the U.S. Court of Appeals for the District of Columbia Circuit affirmed the ruling of the U.S. District Court for the District of Columbia and the FDA to grant 5-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire U.S. Inc. under the name Vyvanse.
The 5-year exclusivity period for Vyvanse expires on February 23, 2012. Vyvanse is further protected by U.S. patents, the first of which expires on June 29, 2023. As a result of the ruling, generic manufacturers cannot submit an abbreviated new drug application (ANDA) to the FDA until February 23, 2011.