Tarceva Drug Patent Profile
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When do Tarceva patents expire, 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.
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: | 4,270 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Butler University | Phase 1 |
Indiana University | Phase 1 |
Hala Fadda | Phase 1 |
Pharmacology for Tarceva
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Tarceva
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-002 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-003 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-001 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Osi Pharms | TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743-002 | Nov 18, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Yugoslavia | 34202 | ⤷ Try a Trial | |
Hungary | 226857 | N-(3-etinilfenil)-6,7-bisz(2-metoxietoxi)-4-kinazolinamin-hidroklorid stabil polimorf módosulatát tartalmazó gyógyszerkészítmény (PHARMACEUTICAL COMPOSITIONS CONTAINING STABLE POLYMORPH OF N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE HYDROCHLORIDE) | ⤷ Try a Trial |
European Patent Office | 2295415 | ⤷ Try a Trial | |
Australia | 7939101 | ⤷ Try a Trial | |
Argentina | 002723 | COMPUESTOS DERIVADOS DE QUINAZOLINA Y PROCEDIMIENTO PARA PREPARARLOS, COMPUESTO INTERMEDIARIOS UTILES EN DICHO PROCEDIMIENTO, SU USO | ⤷ Try a Trial |
Australia | 784243 | ⤷ 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 | 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 | 300214 | Netherlands | ⤷ Try a Trial | 300214, 20150606, EXPIRES: 20200320 |
0817775 | SPC001/2006 | Ireland | ⤷ Try a Trial | SPC001/2006: 20070817, EXPIRES: 20200320 |
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 | C00817775/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
0817775 | C300214 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |