Shire says FDA reaffirms 5-year market exclusivity period for ADHD drug Vyvanse
Shire says FDA reaffirms Vyvanse exclusivity
Associated Press | Oct 26, 09 7:23 AM CDT in
Business
Shire PLC said the U.S. Food and Drug Administration reaffirmed a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity.
The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until Feb. 23, 2012. GlaxoSmithKline's sales force helps to promote the drug in the U.S. Vyvanse had sales of $318.9 million in 2008.
Generic drug developer Actavis Elizabeth LLC has asked the FDA for approval on a generic version of the drug, but the agency previously denied the application. Actavis filed a lawsuit against the FDA in February.
Shares of Shire, which is based in Ireland, closed at $50.53 Monday.
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