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Last Updated: March 28, 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

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SponsorPhase
Netherlands Institute for the Study of CrimePhase 3
University of Geneva, SwitzerlandPhase 3
Stéphanie BaggioPhase 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 021121-004 Apr 1, 2002 ⤷  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
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 021121-004 Apr 1, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CONCERTA

See the table below for patents covering CONCERTA around the world.

Country Patent Number Title Estimated Expiration
Japan H0575725 ⤷  Try a Trial
Japan 5215347 ⤷  Try a Trial
South Africa 9709605 ⤷  Try a Trial
Israel 140020 DOSAGE FORM FOR ACHIEVING AN ASCENDING PLASMA CONCENTRATION PROFILE FOLLOWING ADMINISTRATION FOR AN EXTENDED TIME PERIOD ⤷  Try a Trial
Norway 330235 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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