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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 five patents protecting this drug and two Paragraph IV challenges.

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:5
Applicants:1
NDAs:1
Suppliers: see list4

Pharmacology for Tradename: CONCERTA

Clinical Trials for: CONCERTA

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, 2000RXNo9,000,038*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes8,163,798*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002RXNo8,629,179*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000RXNo6,930,129*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000RXNo8,629,179*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
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers<disabled in preview>
2,015,125,493<disabled in preview>
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms<disabled in preview>
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms<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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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