TARCEVA Drug Patent 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.
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tarceva
A generic version of TARCEVA was approved as erlotinib hydrochloride by RISING on June 11th, 2014.
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Summary for TARCEVA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 240 |
| Clinical Trials: | 428 |
| Patent Applications: | 873 |
| Drug Prices: | Drug price information for TARCEVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TARCEVA |
| What excipients (inactive ingredients) are in TARCEVA? | TARCEVA excipients list |
| DailyMed Link: | TARCEVA at DailyMed |
Recent Clinical Trials for TARCEVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hala Fadda | Phase 1 |
| Butler University | Phase 1 |
| Indiana University | Phase 1 |
Pharmacology for TARCEVA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-002 | Nov 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-002 | Nov 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TARCEVA
See the table below for patents covering TARCEVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2632556 | POLYMORPHE STABLE DE CHLORHYDRATE DE N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE, ET METHODES DE PRODUCTION ET UTILISATIONS PHARMACEUTIQUES DUDIT POLYMORPHE (STABLE POLYMORPH OF N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHARMACEUTICAL USES THEREOF) | ⤷ Sign Up |
| Hong Kong | 1049663 | ⤷ Sign Up | |
| 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) | ⤷ Sign Up |
| African Intellectual Property Organization (OAPI) | 10277 | Quinazoline derivatives | ⤷ Sign Up |
| Slovakia | 38796 | 4-(SUBSTITUTED PHENYLAMINO)QUINAZOLINE DERIVATIVES, QUINAZOLINE DERIVATIVES, PROCESS FOR PRODUCING SAME AND PHARMACEUTICAL COMPOSITIONS ON THEIR BASE | ⤷ Sign Up |
| Colombia | 4410333 | DERIVADOS DE QUINAZOLINA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TARCEVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0817775 | 91209 | Luxembourg | ⤷ Sign Up | 91209, EXPIRES: 20200321 |
| 0817775 | C00817775/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0817775 | SPC/GB06/008 | United Kingdom | ⤷ Sign Up | 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 | SPC001/2006 | Ireland | ⤷ Sign Up | SPC001/2006: 20070817, EXPIRES: 20200320 |
| 0817775 | C300214 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321 |
| 0817775 | 06C0010 | France | ⤷ Sign Up | 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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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 verification 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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