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:3/28/2017)... ... March 28, 2017 , ... Z-Medica, LLC, a leading developer ... Center (UPMC) will acquire QuikClot® Bleeding Control Kits® (BCK) to equip up to ... with efforts by the American College of Surgeons, U.S. Department of Defense, Department ...
(Date:3/28/2017)... ... 28, 2017 , ... Award-winning medical group Allied Anesthesia today ... board chair for Orange County health care system CalOptima Friday. CalOptima announced its ... chair Mark Refowitz’s term, which runs through June 30 of this year, until ...
(Date:3/28/2017)... Appleton, WI (PRWEB) , ... March 28, 2017 ... ... how self-funded health plans work, the Self-Funding Success website has recently developed and ... about Self-Funded Health Plans ” was created based on common inquiries the site’s ...
(Date:3/28/2017)... , ... March 28, 2017 , ... ... of SkyLex Advanced Surgical, Inc. is thrilled to offer the recently FDA-approved Obalon ... and this procedure adds to SkyLex Advanced Surgical’s already comprehensive list of ...
(Date:3/28/2017)... ... ... Oily skin is a common and unwelcomed occurrence in people of all ages, genders and ... to the discussion of dealing with excess skin oil. “Oily skin is a challenge to ... can help remove the oily shine while keeping the skin fresh and clean,” says Dr. ...
Breaking Medicine News(10 mins):
(Date:3/28/2017)... 2017 Summary ... as a Key Component of Multichannel Marketing" provides ... landscape in the digital age. While the ... medical advancements, it has been much slower to ... on traditional channels and methods. However, the decreasing ...
(Date:3/28/2017)... , March 29, 2017 Center ... Siteless CRO platform, announced today study results presented ... Care Pharmacy, #AMCP2017, Managed Care and Specialty Pharmacy ... . Data in both posters demonstrated that pharmacist-led patient ... protocol adherence. These factors are crucial to generating the ...
(Date:3/28/2017)... CAMBRIDGE , United Kingdom and  BOSTON ... text analytics provider Linguamatics today announced ... Dow Jones . The agreement allows pharmaceutical companies ... utilizing Linguamatics I2E text mining technology. ... used by 18 of the top 20 global ...
Breaking Medicine Technology: