Ortho-McNeil-Janssen Pharmaceuticals, Inc (OMJPI ) has entered into a supply and distribution agreement with Watson Laboratories, Inc to distribute an authorized generic version of Concerta (methylphenidate HCl extended-release tablets). Watson will launch the authorized generic beginning May 1, 2011.
“The availability of an authorized generic version of Concerta that is both bioequivalent and clinically equivalent to the complex, extended-release innovator compound is particularly important -- and reassuring -- for patients with ADHD and their families,” states Don Heald, vice president Clinical Pharmacology, Neurosciences, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. “It is also important for healthcare professionals who may consider prescribing a generic product for this condition.”
In 2004, the affiliate of OMJPI that marketed Concerta at that time filed a Citizen Petition requesting generic versions of Concerta demonstrate a similar onset of efficacy and a similar duration of effect to the innovator product. The Citizen Petition, which remains under review by the Food and Drug Administration (FDA), is not impacted by this agreement. McNeil Pediatrics, a division of OMJPI, will continue to market the branded Concerta product.
Under the terms of the agreement, OMJPI will manufacture and exclusively supply Watson with the authorized generic product, which will be available in 18mg, 27mg, 36mg, and 54mg formulations. Watson will market and distribute the product in the United States until the end of 2014.
Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages six to 17 and in adults 18 to 65, as part of a total treatment program that may include counselling or other therapies.