Watson will launch the authorized generic beginning May 1, 2011. OMJPI is a subsidiary of Johnson & Johnson and a provider of medicines for an array of health concerns.
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.
According to OMJPI, 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. Children under six years of age should not take CONCERTA.
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.
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 FDA, is not impacted by this agreement. McNeil Pediatrics, a division of OMJPI, will continue to market the branded CONCERTA product.
Don Heald, vice president of clinical pharmacology, neurosciences and Johnson & Johnson Pharmaceutical research & development, said: “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.
“It is also important for healthcare professionals who may consider prescribing a generic product for this condition.”
Will the deal commercially benefit the firms?
Have your say and discuss with your peers on the InfoGrok community.
Participate by posting your comments now.