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Serving leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
UBS
Daiichi Sankyo
Deloitte
McKinsey
US Army
McKesson
Argus Health
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Generated: December 18, 2017

DrugPatentWatch Database Preview

TARCEVA Drug Profile

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Which patents cover Tarceva, and what generic alternatives are available?

Tarceva is a drug marketed by Osi Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in fifty countries and nine supplementary protection certificates in eight countries.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Drug patent expirations by year for TARCEVA

Pharmacology for TARCEVA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for TARCEVA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► SubscribeY► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► SubscribeY► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-002Nov 18, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► Subscribe► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-002Nov 18, 2004RXYesNo► Subscribe► SubscribeY► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► Subscribe► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
Osi PharmsTARCEVAerlotinib hydrochlorideTABLET;ORAL021743-002Nov 18, 2004RXYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for TARCEVA

Drugname Dosage Strength RLD Submissiondate
erlotinib hydrochlorideTablets25 mg, 100 mg and 150 mgTarceva11/18/2008

International Patent Family for Tradename: TARCEVA

Country Document Number Estimated Expiration
CroatiaP960147► Subscribe
Spain2320408► Subscribe
Spain2332984► Subscribe
Czech Republic294967► Subscribe
Canada2632556► Subscribe
World Intellectual Property Organization (WIPO)0134574► Subscribe
Czech Republic9600931► Subscribe
Morocco23831► Subscribe
European Patent Office1233948► Subscribe
South Africa200203130► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TARCEVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/008United Kingdom► SubscribePRODUCT 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
C0010France► SubscribePRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
00214Netherlands► SubscribePRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
209Luxembourg► Subscribe91209, EXPIRES: 20200321
C001/2006Ireland► SubscribeSPC001/2006: 20070817, EXPIRES: 20200320
2006 00006Denmark► Subscribe
2006Austria► SubscribePRODUCT 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
0214Netherlands► Subscribe300214, 20150606, EXPIRES: 20200320
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Serving leading biopharmaceutical companies globally:

Chubb
AstraZeneca
Novartis
Covington
Mallinckrodt
UBS
Healthtrust
Express Scripts
Federal Trade Commission
QuintilesIMS

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