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Last Updated: March 18, 2024

CONCERTA Drug Patent Profile


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When do Concerta patents expire, and when can generic versions of Concerta launch?

Concerta is a drug marketed by Janssen Pharms and is included in one NDA.

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

Drug patent expirations by year for CONCERTA
Drug Prices for CONCERTA

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Drug Sales Revenue Trends for CONCERTA

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Recent Clinical Trials for CONCERTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stéphanie BaggioPhase 3
School of Health Sciences FribourgPhase 3
University of LausannePhase 3

See all CONCERTA clinical trials

Pharmacology for CONCERTA
Paragraph IV (Patent) Challenges for CONCERTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CONCERTA Extended-release Tablets methylphenidate hydrochloride 18 mg*, 27 mg, 36 mg and 54 mg 021121 2005-07-19

US Patents and Regulatory Information for 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;ORAL 021121-001 Aug 1, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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. 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 verification 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.