The ANDA is concerned with generic version of Shire’s Adderall XR capsules, which had US sales, including brand and generic sales, of $2bn as of 31 December 2012 based on IMS sales data.
Adderall XR extended-release capsules affect certain chemicals in the brain that may affect attention span and behavior.
Under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Barr Pharmaceuticals, Teva’s subsidiary, Teva sells a generic version of Adderall XR capsules.
The agreement allows Teva the right to be supplied product by Shire through 1 April 2014.