Navigation Links
District Court Decision Received in CONCERTA(R) Patent Case
Date:3/31/2009

TITUSVILLE, N.J., March 31 /PRNewswire/ -- 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(R) (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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090331/CG92295LOGO)

About CONCERTA(R)

CONCERTA(R) 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(R) extended-release methylphenidate tablets are both bioequivalent and clinically equivalent to the innovator product.

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.

For full prescribing information, go to www.concerta.net.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition, which includes a variable attention span and/or hyperactivity or impulsivity. According to the National Institutes of Health (NIH), ADHD is one of the most common psychiatric disorders in childhood. It affects an estimated four million children and an estimated eight million adults in the United States. Studies suggest that between 30 and 70 percent of children with ADHD continue to have symptoms as adults.

About McNeil Pediatrics

McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), markets CONCERTA(R) for the treatment of children, adolescents and adults with ADHD in the United States. For more information, visit www.mcneilpediatrics.net.

CONCERTA(R) and OROS(R) are a registered trademark of ALZA Corporation.

    Contacts:

    Media                                    Investors
    -----                                    ---------
    Tricia Geoghegan: (609) 730-3746         Louise Mehrotra: (732) 524-6491

    Sri Ramaswami (609) 647-8195             Lesley Fishman (732) 524-3922


'/>"/>
SOURCE McNeil Pediatrics
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Vitamin Relief Brings Needed Nutrition to School District Resurrecting After Katrina
2. Autism Speaks Applauds Supreme Court Decision Upholding Families Right to Challenge IEPs Without First Trying Out School District Proposed Placement
3. AstraZeneca Response to November 2, 2007 Ruling In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts
4. Another Medtronic Sprint Fidelis Lead Lawsuit is Filed in Federal District Court
5. Schering-Plough Reports U.S. District Court for District of Massachusetts Finds No Liability for Subsidiary in AWP Case
6. Regence Partners with Multnomah Education Service District to Bring Free Health Services to more than 20,000 Students in Need
7. Virginia School District Gets Proactive Against MRSA
8. New Democracy Corps Battleground Poll of Swing Districts Finds Strong, Bi-Partisan Opposition to Cutting Medicare-Funded Nursing Home Care
9. EPA Awards $154,848 Grant to Canton Local School District for Clean School Bus Project
10. Health Care Districts Board Chair Nationally Recognized as a Modern Healthcare Trustee of the Year
11. Lead Safe D.C. and HSCSN Bring Lead Poisoning Prevention to The Districts Children With Special Needs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that covers ... companies have a waiver for care if the client has a cognitive impairment diagnosis. ... pays for care, is often waived, so the benefits from their insurance start immediately,” ...
(Date:10/13/2017)... New York, NY (PRWEB) , ... October 13, 2017 , ... ... most influential people in business to advocate for action towards gender equality at their ... 18,000 views from around the globe, and reached a social audience of over 3 ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 11, 2017  Caris Life Sciences ® , a ... promise of precision medicine, today announced that St. Jude ... Oncology Alliance™ (POA) as its 17 th member. ... Jude Crosson Cancer Institute will help develop standards of ... tumor profiling, making cancer treatment more precise and effective. ...
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical Services, ... solutions for injectable drug administration, today shared the results ... Adapter for improving the intradermal administration of polio vaccines. ... Vaccination Summit in May 2017 by Dr. Ondrej ... Department, World Health Organization (WHO), and recently published in ...
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease ... end of October . PhysicianOne Urgent Care is helping communities across ... Westchester, NY , by offering no-cost* flu shots through the end ... mandated by certain health insurance regulations. ... The best time to get a flu shot is by the end ...
Breaking Medicine Technology: