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Last Updated: July 4, 2020

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TARCEVA Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in thirty-eight countries.

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

Drug patent expirations by year for TARCEVA
Drug Prices for TARCEVA

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Recent Clinical Trials for TARCEVA

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SponsorPhase
Ulrik LassenPhase 2
Indiana UniversityPhase 1
Butler UniversityPhase 1

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Pharmacology for TARCEVA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for TARCEVA
Tradename Dosage Ingredient NDA Submissiondate
TARCEVA TABLET;ORAL erlotinib hydrochloride 021743 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 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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 TARCEVA

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

Supplementary Protection Certificates for TARCEVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 91209 Luxembourg   Start Trial 91209, EXPIRES: 20200321
0817775 C300214 Netherlands   Start Trial PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775 300214 Netherlands   Start Trial 300214, 20150606, EXPIRES: 20200320
0817775 SPC001/2006 Ireland   Start Trial SPC001/2006: 20070817, EXPIRES: 20200320
0817775 C00817775/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0817775 06C0010 France   Start Trial 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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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Mallinckrodt
Baxter
McKesson
Harvard Business School

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