Ortho-McNeil-Janssen Pharmaceuticals, Inc. 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, PhD, 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.