FDA approves Teva generic attention deficit hyperactivity disorder therapy

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.