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TARCEVA Drug Profile

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Which patents cover Tarceva, and what substitute generic drugs 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 nineteen patent family members in fifty 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.

Summary for Tradename: TARCEVA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list139
Clinical Trials: see list245
Patent Applications: see list10,528
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TARCEVA at DailyMed

Pharmacology for Tradename: TARCEVA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXYesNo5,747,498*PED► SubscribeY► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-003Nov 18, 2004RXYesYesRE41065*PED► Subscribe ► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXYesNoRE41065*PED► Subscribe ► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-002Nov 18, 2004RXYesNo► Subscribe► Subscribe
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Paragraph IV activity 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
World Intellectual Property Organization (WIPO)0134574► Subscribe
Germany122005000053► Subscribe
South Korea100232335► Subscribe
Brazil0015544► Subscribe
Cyprus1112671► 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
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
00214Netherlands► SubscribePRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
C0010France► SubscribePRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
0817775/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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