PHILADELPHIA The U.S. District Court for the District of Columbia has upheld a decision by the Food and Drug Administration to give exclusivity to a Shire drug for attention-deficit hyperactivity disorder, Shire announced Thursday.
The FDA gave the ADHD drug Vyvanse (lisdexamfetamine diemsylate) five years of market exclusivity on account of its being a new chemical entity in 2007. For that reason, it refused to file an approval application for a generic version of the drug submitted by Actavis Elizabeth. Actavis sued the FDA in February 2009 in the court to challenge the FDA decision.
The five-year exclusivity period for Vyvanse will expire in February 2012, precluding generic manufacturers from submitted applications for knock-off versions until then, or until February 2011, if a generic applicant challenges the drug’s patents, which expire in June 2023.