FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Feb 14 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire's Adderall XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR® had annual sales, including brand and generic sales, of approximately $2 billion in the United States, based on IMS sales data as of December 31, 2012.

Teva currently sells a generic version of Adderall XR® Capsules under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Teva's subsidiary Barr Pharmaceuticals. Under the terms of the agreement, Teva has the right to be supplied product by Shire through April 1, 2014.