Shire receives market exclusivity for ADHD drug

DUBLIN, Ireland A new drug for treating attention-deficit hyperactivity disorder properly received its five-year market exclusivity from the Food and Drug Administration, the drug’s manufacturer announced.

British drug maker Shire said the FDA confirmed the new chemical entity exclusivity given to Vyvanse (lisdexamfetamine dimesylate). The drug’s exclusivity period will last until February 2012, and its patents will remain in effect until June 2023.

Generic drug maker Actavis had sued the FDA in the District Court of the District of Columbia challenging the agency’s decision to grant Vyvanse status as a new chemical entity following its refusal to file Actavis’ approval application for a generic version of the drug. The court case was stayed pending the outcome of the FDA’s review.