tarceva Drug Patent Profile

✉ Email this page to a colleague

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.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for tarceva?
What are the global sales for tarceva?
What is Average Wholesale Price for tarceva?

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

Drug patent expirations by year for tarceva

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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

Subscribe to access the full database, or Sign Up
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
>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.

Subscribe to access the full database, or Sign Up
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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tarceva

Subscribe to access the full database, or Sign Up
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description