FDA grants 6 months more to Shire
Shire Pharmaceuticals has been granted an additional six months market exclusivity by the FDA for Shire's Adderall XR (mixed amphetamine salts), the leading brand in the U.S for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Shire Pharmaceuticals has been granted an additional six months market exclusivity by the FDA for Shire's Adderall XR (mixed amphetamine salts), the leading brand in the U.S for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The extension provides US market exclusivity until April 11, 2005 under the Hatch-Waxman regulations. In its letter, the FDA confirmed that Shire met the terms of a written request to provide data from a clinical program examining the effect of Adderall XR in adolescent pediatric patients. The additional studies performed under this agreement will provide critical clinical data for its use in adolescents.
Adderall XR is protected by patents which expire in 2018. Sales of the drug for the 6 months ended June 30, 2004 were US$283m. IMS data show that the brand has the number one share (24.50%) of the total US ADHD market for prescribed treatments. The ADHD market grew by around 20% in the last year and it is anticipated to continue growing as diagnosis improves in pediatric, adolescents and adult patients.