TARCEVA Drug Patent Profile

When do Tarceva patents expire, 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tarceva

A generic version of TARCEVA was approved as erlotinib hydrochloride by RISING on June 11^th, 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:	19
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

See drug prices for TARCEVA

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

See all TARCEVA clinical trials

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
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004		DISCN	Yes	No
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004		DISCN	Yes	No

Expired US Patents for TARCEVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004

International Patents for TARCEVA

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112671
Hong Kong	1049663
Croatia	P20020388	POSTOJAN POLIMORFNI OBLIK N-(3-ETINILFENILAMINO)-6,7-BIS(2-METOKSIETOKSI)-4-KINAZOLINAMIN HIDROKLORIDA: METODE NJEGOVA DOBIVANJA I UPORABA (STABLE POLYMORPH OF N-(3-ETHYNYLPHENYLAMINO)-6,7-BIS(2-METHOXYETHOXY)-4-QUI-NAZOLINAMINE HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHARMACEUTICAL USES THEREOF)
New Zealand	286263	4 (SUBSTITUTED PHENYLAMINO) QUINAZOLINE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF
Ukraine	74803	СТОЙКИЙ ПОЛИМОРФ ГИДРОХЛОРИДА N-(3-ЭТИНИЛФЕНИЛ)-6,7-БИС(2-МЕТОКСИЭТОКСИ)-4-ХИНАЗОЛИНАМИНА, СПОСОБ ЕГО ПОЛУЧЕНИЯ (ВАРИАНТЫ) И ФАРМАЦЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ;СТІЙКИЙ ПОЛІМОРФ ГІДРОХЛОРИДУ N-(3-ЕТИНІЛФЕНІЛ)-6,7-БІС(2-МЕТОКСІЕТОКСИ)-4-ХІНАЗОЛІНАМІНУ, СПОСІБ ЙОГО ОДЕРЖАННЯ (ВАРІАНТИ) ТА ФАРМАЦЕВТИЧНЕ ЗАСТОСУВАННЯ (a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyeToxy)-4-quinazolinamine hydrochloride, a method for producing thereof (variants) and pharmaceutical use)
Japan	H10506633
Canada	2216796	DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES)

Supplementary Protection Certificates for TARCEVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817775	300214	Netherlands		300214, 20150606, EXPIRES: 20200320
0817775	SPC001/2006	Ireland		SPC001/2006: 20070817, EXPIRES: 20200320
0817775	5/2006	Austria		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	CA 2006 00006	Denmark
0817775	SPC/GB06/008	United Kingdom		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	C300214	Netherlands		PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775	06C0010	France		PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321