Market exclusivity for Shire's VYVANSE upheld on appeal
This article was originally published in Scrip
The US Court of Appeals for the District of Columbia Circuit has confirmed that Shire Pharmaceuticals' attention deficit hyperactivity disorder (ADHD) product VYVANSE retains its New Chemical Entity exclusivity status until February 23rd 2012. Consequently, generic manufacturers, including Actavis which had originally sued the US FDA in the District Court of Columbia, cannot submit an ANDA to FDA until February 23, 2011.
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