Watson Pharmaceuticals Inc. next spring plans to release an authorized generic version of Concerta (methylphenidate hydrochloride) extended-release tablets for the treatment of attention deficit hyperactivity disorder (ADHD).


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Watson to market authorized generic for ADHD

November 3rd, 2010

MORRISTOWN, N.J. – Watson Pharmaceuticals Inc. next spring plans to release an authorized generic version of Concerta (methylphenidate hydrochloride) extended-release tablets for the treatment of attention deficit hyperactivity disorder (ADHD).

The company said Tuesday that its Watson Laboratories Inc. subsidiary has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, to offer the authorized generic Concerta, which is slated to launch May 1, 2011.

Under the agreement, Ortho-McNeil-Janssen will manufacture and supply Watson with all dosage strengths (18 mg, 27 mg, 36 mg and 54 mg) of the authorized generic product. Watson will market and distribute the product in the United States, and Ortho-McNeil-Janssen 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 Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and to launch its own ANDA product at the end of the exclusive supply pact.

"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," Watson president and chief executive officer Paul Bisaro said in a statement.

Concerta had sales of about $1.3 billion for the 12 months ended June 30, according to IMS Health data provided by Watson.

"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," commented Don Heald, vice president of clinical pharmacology, neurosciences, at Johnson & Johnson Pharmaceutical Research & Development LLC. "It is also important for health care professionals who may consider prescribing a generic product for this condition."

Ortho-McNeil-Janssen said Concerta is approved for the treatment of ADHD in children ages 6 to 17 and in adults ages 18 to 65 as part of a total treatment program that may include counseling or other therapies.

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