CONCERTA(R) Patent Appeal Denied
TITUSVILLE, N.J., April 26 The Court of Appeals for the Federal Circuit has denied an appeal by McNeil Pediatrics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., to overturn a 2009 decision by the U.S. District Court of Delaware that the patent for CONCERTA (methylphenidate HCl) Extended-Release Tablets CII is invalid and not infringed by Andrx Corporation.
In December 2007, McNeil Pediatrics, which markets CONCERTA, and ALZA Corporation, the owner of the CONCERTA patent, sued Andrx Corporation for infringement of the CONCERTA patent that expires in July 2017, with pediatric exclusivity extending until January 2018.
In March 2009, the court ruled on that case in favor of Andrx. McNeil Pediatrics and ALZA Corporation filed an appeal of that decision in the Federal Circuit, which rendered today's decision.
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. McNeil Pediatrics will continue to market CONCERTA.
About McNeil Pediatrics(TM)
McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of children, adolescents, adults and healthcare professionals through the development of therapies specifically formulated for children, adolescents and adults. McNeil Pediatrics(TM) is a leader in the treatment of ADHD and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, N.J. Visit www.McNeilPediatrics.net for more information.
CONCERTA® is a prescription product approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents and adults ages 6 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 (greater than 5 percent) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (greater than 10 percent) reported in adults were dry mouth, nausea, decreased appetite, headache and insomnia.
Visit http://www.concerta.net/concerta/pages/full.jsp for complete Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
CONCERTA® and OROS® are registered trademarks of ALZA Corporation.
SOURCE McNeil Pediatrics
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