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Profile for Tradename: CONCERTA

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Concerta is a drug marketed by Janssen Pharms and is included in one NDA. It is available from four suppliers. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-seven patent family members in seventeen countries.

The generic ingredient in CONCERTA is methylphenidate hydrochloride. There are twenty-four drug master file entries for this compound. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: CONCERTA

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list32

Pharmacology for Tradename: CONCERTA

Clinical Trials for: CONCERTA

Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers
Status: Completed Condition: Pharmacokinetics

A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV
Status: Recruiting Condition: HIV Dementia

A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Status: Completed Condition: Healthy

Methylphenidate Study in Breast or Gastrointestinal Cancer Patients
Status: Terminated Condition: Breast Cancer; Fatigue; Gastrointestinal Cancer

A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Status: Completed Condition: ADHD

CONCERTA Lab School Study
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Status: Completed Condition: Attention Deficit Hyperactivity Disorder; INSOMNIA

Lab School Day Study for CONCERTA of Older Children With ADHD
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000RXNo9,029,416<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000RXNo6,919,373*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes6,919,373*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002RXNo9,029,416<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000RXNo8,163,798*PED<disabled>Y<disabled>
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Paragraph IV activity for: CONCERTA

Drugname Dosage Strength RLD Submissiondate
methylphenidate hydrochlorideExtended-release Tablets18 mg*, 27 mg, 36 mg and 54 mgConcerta7/19/2005
metformin hydrochlorideExtended-release Tablets18 mg, 27 mg, 36 mg and 54 mgConcerta7/19/2005

Non-Orange Book Patents for Tradename: CONCERTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms<disabled in preview>
2,015,125,493<disabled in preview>
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms<disabled in preview>
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers<disabled in preview>
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers<disabled in preview>
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International Patent Family for Tradename: CONCERTA

Country Document Number Publication Date
China1209098Jul 06, 2005
World Intellectual Property Organization (WIPO)9823263Jun 04, 1998
Denmark0946151Aug 28, 2006
Australia5267698Jun 22, 1998
European Patent Office1690531Jan 20, 2010
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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