US Pharm. 2010;35(12):104.Watson Pharmaceuticals, Inc., announced that its subsidiary, Watson Laboratories, Inc., has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) to market and distribute the authorized generic version of Concerta (methylphenidate hydrochloride extended-release tablets) in the United States. Watson will launch its authorized generic of Concerta on May 1, 2011.
Concerta is indicated for the treatment of attention-deficit hyperactivity disorder. OMJPI will receive a share of the net sales from Watson's sales of the product. During the term of the agreement, which runs through 2014, Watson will be permitted to continue to pursue FDA approval of its ANDA for a generic version of Concerta and can launch its own ANDA product at the end of the agreement.“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.