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Serving 500+ biopharmaceutical companies globally:

Colorcon
US Army
Johnson and Johnson
Boehringer Ingelheim
Federal Trade Commission
Mallinckrodt
Queensland Health
Deloitte
Cipla
Accenture

Generated: August 17, 2017

DrugPatentWatch Database Preview

CONCERTA Drug Profile

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What is the patent landscape for Concerta, and what generic Concerta alternatives are available?

Concerta is a drug marketed by Janssen Pharms and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

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

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

Summary for Tradename: CONCERTA

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list15
Clinical Trials: see list82
Patent Applications: see list2,393
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:CONCERTA at DailyMed

Pharmacology for Tradename: CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
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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► Subscribe
2,015,125,493► Subscribe
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
6,034,101 United States Patent: 6034101   ( 1► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CONCERTA

Country Document Number Estimated Expiration
China1231603► Subscribe
World Intellectual Property Organization (WIPO)9814168► Subscribe
Portugal1083879► Subscribe
Portugal932388► Subscribe
New Zealand508567► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Farmers Insurance
Novartis
Baxter
Merck
Dow
AstraZeneca
Medtronic
QuintilesIMS
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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