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.
Watson is expected to launch the authorised generic beginning 1 May 2011.
As per the terms of the agreement, OMJPI is expected to manufacture and exclusively supply Watson with the authorised generic product, which will be available in 18mg, 27mg, 36mg, and 54mg formulations, while Watson will market and distribute the product in the US until the end of 2014.
Johnson & Johnson Pharmaceutical Research & Development Clinical Pharmacology, Neurosciences vice president Don Heald said that the availability of an authorised generic version of Concerta that is both bioequivalent and clinically equivalent to the complex, extended-release compound is particularly important for patients with ADHD and their families.
"It is also important for healthcare professionals who may consider prescribing a generic product for this condition," Heald said.