Watson introduces generic version of Concerta

May 2 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., has launched an authorized generic version of Concerta® (methylphenidate hydrochloride extended-release tablets) as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI).  Watson began shipping the product today.  Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies.

Under the terms of the exclusive supply and distribution agreement, OMJPI manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the United States. OMJPI will receive a share of the net sales from Watson's sales of the product. The agreement runs until the end of 2014. During the term of the agreement, Watson may continue to pursue U.S. Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and may launch its own ANDA product at the conclusion of the exclusive supply agreement. Other terms of the agreement have not been disclosed.

For the most recent twelve months ending February 28, 2011, Concerta had sales of approximately $1.5 billion, according to IMS Health data.