The U.S. District Court for the District of Delaware has rendered a decision in the patent litigation between Alza Corporation, McNeil-PPC, Inc. and Andrx Pharmaceuticals LLC. McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which markets Concerta (methylphenidate HCI) Extended-Release Tablets CII, said the court held that the patent in suit is not valid or infringed by the filing of Andrx's Abbreviated New Drug Application.
Alza and McNeil-PPC are analyzing the court's lengthy opinion and assessing their next steps in this litigation, which may include a request for reconsideration, or an appeal to the Court of Appeals for the Federal Circuit.
Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies. McNeil previously filed a Citizen's Petition with the FDA requesting the Agency to apply additional bioequivalence metrics to ensure that the approval of any generic versions of Concerta extended-release methylphenidate tablets are both bioequivalent and clinically equivalent to the innovator product.
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.