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Last Updated: March 28, 2024

tarceva Drug Patent Profile


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Which patents cover Tarceva, 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.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 DISCN 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 tarceva

International Patents for tarceva

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

Country Patent Number Title Estimated Expiration
Bulgaria 65880 ⤷  Try a Trial
European Patent Office 1110953 Dérivés de quinazolinone (Quinazoline derivatives) ⤷  Try a Trial
Turkey 9600265 ⤷  Try a Trial
Denmark 0817775 ⤷  Try a Trial
Bulgaria 106761 ⤷  Try a Trial
Slovenia 9600102 QUINAZOLINE DERIVATIVES ⤷  Try a Trial
European Patent Office 0817775 DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tarceva

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 C00817775/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0817775 SPC/GB06/008 United Kingdom ⤷  Try a Trial 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 91209 Luxembourg ⤷  Try a Trial 91209, EXPIRES: 20200321
0817775 CA 2006 00006 Denmark ⤷  Try a Trial
0817775 5/2006 Austria ⤷  Try a Trial 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 ⤷  Try a Trial SPC001/2006: 20070817, EXPIRES: 20200320
0817775 06C0010 France ⤷  Try a 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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