OMJPI enters agreement with Watson to distribute generic version of CONCERTA tablets

Nov 3 2010

Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) today announced it 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.

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.

IMPORTANT SAFETY INFORMATION

Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

CONCERTA should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure.  Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA.  Your child's healthcare professional should check height and weight often and may interrupt CONCERTA treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles.  Caution should be used accordingly until you are reasonably certain that CONCERTA does not adversely affect your ability to engage in such activities.

The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain.  The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

CONCERTA contains methylphenidate, a Schedule II controlled substance under the Controlled Substances Act.