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Last Updated: May 26, 2022

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. Eleven 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

See drug prices for TARCEVA

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

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 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for TARCEVA

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

Country Patent Number Title Estimated Expiration
Egypt 24229 See Plans and Pricing
Czech Republic 294967 4-(Substituovaný fenylamino)chinazolinové deriváty, způsob jejich výroby a použití a farmaceutické prostředky na jejich bázi (4-(Substituted phenylamino)quinazoline derivatives, process of their preparation and pharmaceutical compositions based thereon) See Plans and Pricing
Denmark 0817775 See Plans and Pricing
Austria 205483 See Plans and Pricing
Germany 122005000053 See Plans and Pricing
Slovakia 5812002 STABLE POLYMORPH OF N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2- METHOXYETHOXY)-4-QUINAZOLINAMINE HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHARMACEUTICAL USES THEREOF See Plans and Pricing
New Zealand 286263 4 (SUBSTITUTED PHENYLAMINO) QUINAZOLINE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TARCEVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 06C0010 France See Plans and Pricing PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
0817775 CA 2006 00006 Denmark See Plans and Pricing
0817775 300214 Netherlands See Plans and Pricing 300214, 20150606, EXPIRES: 20200320
0817775 C00817775/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0817775 SPC/GB06/008 United Kingdom See Plans and Pricing PRODUCT NAME: ERLOTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR POLYMORPH THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: CH 5726601 20050321; CH 5726602 20050321; CH 5726603 20050321; UK EU/1/05/311/001 20050919; UK EU/1/05/311/002 20050919; UK EU/1/05/311/003 20050919
0817775 5/2006 Austria See Plans and Pricing 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 SPC001/2006 Ireland See Plans and Pricing SPC001/2006: 20070817, EXPIRES: 20200320
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Mallinckrodt
Baxter
McKesson
Harvard Business School

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