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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Chinese Patent Office
Chubb
US Army
Dow
Colorcon
US Department of Justice
Teva
McKinsey

Generated: October 20, 2017

DrugPatentWatch Database Preview

CONCERTA Drug Profile

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What is the patent landscape for Concerta, and when can generic versions of Concerta launch?

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 seventy-two 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-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: CONCERTA

US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list15
Clinical Trials: see list82
Patent Applications: see list2,484
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► Subscribe ► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► 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;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► 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;ORAL021121-001Aug 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
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
7,521,067Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
2,015,125,493► Subscribe
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
6,034,101 United States Patent: 6034101   ( 1► Subscribe
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► 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
China101327196► Subscribe
Hong Kong1035492► Subscribe
South Africa9709605► Subscribe
Israel211081► Subscribe
Norway20101070► Subscribe
Canada2333688► Subscribe
Australia9639101► Subscribe
Norway330235► Subscribe
South Africa200007111► Subscribe
Canada2265668► 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.

Export unavailable in trial.
Subscribe for complete access.

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

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chubb
US Department of Justice
Express Scripts
Fuji
Deloitte
Boehringer Ingelheim
Medtronic
Cipla
Novartis

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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