Watson enters exclusive agreement with OMJPI to market authorized generic Concerta

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), to market the authorized generic version of Concerta® (methylphenidate hydrochloride extended-release tablets).  Watson will launch its authorized generic of Concerta on May 1, 2011.  Concerta is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Under the terms of the agreement, OMJPI will manufacture and exclusively supply Watson with all dosage strengths of the authorized generic product.  Watson will market and distribute 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 will be permitted to continue to pursue U.S. Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and will be permitted to launch its own ANDA product at the conclusion of the exclusive supply agreement.  Other terms of the agreement were not disclosed.

"This agreement ensures that consumers will benefit from a quality, cost effective product beginning in May 2011, removing any uncertainty of when a generic product could be approved," said Paul Bisaro, Watson's President and CEO.    

For the 12-months ending June 30, 2010, Concerta had sales of approximately $1.3 billion, according to IMS Health data.