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Last Updated: November 8, 2024

TARCEVA Drug Patent Profile


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

Tarceva is a drug marketed by Osi Pharms and is included in one NDA.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tarceva

A generic version of TARCEVA was approved as erlotinib hydrochloride by RISING on June 11th, 2014.

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Drug patent expirations by year for TARCEVA
Drug Prices for TARCEVA

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Recent Clinical Trials for TARCEVA

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

SponsorPhase
Hala FaddaPhase 1
Butler UniversityPhase 1
Indiana UniversityPhase 1

See all TARCEVA clinical trials

Pharmacology for TARCEVA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for TARCEVA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TARCEVA Tablets erlotinib hydrochloride 25 mg 021743 1 2008-11-18

US Patents and Regulatory Information for TARCEVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 TARCEVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 ⤷  Sign Up ⤷  Sign Up
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TARCEVA

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

Country Patent Number Title Estimated Expiration
Malaysia 117896 QUINAZOLINE DERIVATIVES ⤷  Sign Up
Mexico 9707453 DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.) ⤷  Sign Up
European Patent Office 1233948 POLYMORPHE STABLE DE CHLORHYDRATE DE N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE, ET METHODES DE PRODUCTION ET UTILISATIONS PHARMACEUTIQUES DUDIT POLYMORPHE (STABLE POLYMORPH OF N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHARMACEUTICAL USES THEREOF) ⤷  Sign Up
Yugoslavia 34202 ⤷  Sign Up
Montenegro P36308 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TARCEVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 300214 Netherlands ⤷  Sign Up 300214, 20150606, EXPIRES: 20200320
0817775 5/2006 Austria ⤷  Sign Up PRODUCT NAME: ERLOTINIB UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE ERLOTINIBHYDROCHLORID; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 - EU/1/05/311/003 20050919; FIRST REGISTRATION: CH 57266 01 - 57266 03 20050321
0817775 C300214 Netherlands ⤷  Sign Up PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775 SPC001/2006 Ireland ⤷  Sign Up SPC001/2006: 20070817, EXPIRES: 20200320
0817775 06C0010 France ⤷  Sign Up PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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