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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Cipla
Cerilliant
Dow
Julphar
Citi
Merck
Deloitte
US Department of Justice

Generated: December 16, 2017

DrugPatentWatch Database Preview

CONCERTA Drug Profile

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When do Concerta patents expire, and what generic 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 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 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 PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen PharmsCONCERTAmethylphenidate hydrochlorideTABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► 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
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
2,015,125,493► Subscribe
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
7,521,067Methods 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
Canada2264852► Subscribe
Australia9639101► Subscribe
Israel140020► Subscribe
Australia5267698► Subscribe
Canada2265668► Subscribe
Australia4801497► Subscribe
Japan2015028095► Subscribe
World Intellectual Property Organization (WIPO)9814168► Subscribe
Germany69735848► Subscribe
Japan2002513392► 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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Serving leading biopharmaceutical companies globally:

Accenture
US Department of Justice
Farmers Insurance
AstraZeneca
Julphar
Merck
Boehringer Ingelheim
Argus Health
Dow
QuintilesIMS

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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