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Watson to distribute generic CONCERTA

Ortho-McNeil-Janssen Pharmaceuticals has granted Watson Laboratories the distribution rights to a generic version of its ADHD drug CONCERTA

Ortho-McNeil-Janssen Pharmaceuticals (OMJPI), a subsidiary of Johnson &Johnson (J&J), has entered into a supply and distribution agreement with Watson Laboratories to distribute an authorised generic version of the Attention Deficit Hyperactivity Disorder (ADHD) therapy CONCERTA (methylphenidate HCl extended-release tablets). The authorised generic will be launched by Watson on May 1, 2011.

CONCERTA is approved for the treatment of ADHD in children aged between six and 17 and in adults aged 18 to 65, as part of a total treatment programme including other therapies such as counselling.

Under the terms of the agreement, the authorised generic product will be manufactured by OMJPI and exclusively supplied to Watson. The drug will be available in 18mg, 27mg, 36mg, and 54mg formulations and will be marketed and distributed in the US by Watson until the end of 2014.

"The availability of an authorised 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," said Dr Don Heald, vice president clinical pharmacology, neurosciences, Johnson & Johnson pharmaceutical research and development. "It is also important for healthcare professionals who may consider prescribing a generic product for this condition," he continued.

The branded version of CONCERTA will continue to be marketed by McNeil Paediatrics, a division of OMJPI.

4th November 2010

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