ERLOTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for erlotinib hydrochloride and what is the scope of patent protection?

Erlotinib hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, Zydus Pharms, and Osi Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for erlotinib hydrochloride. Thirteen suppliers are listed for this compound.

Summary for ERLOTINIB HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	833
Patent Applications:	19
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERLOTINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in ERLOTINIB HYDROCHLORIDE?	ERLOTINIB HYDROCHLORIDE excipients list
DailyMed Link:	ERLOTINIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ERLOTINIB HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
State University of New York - Downstate Medical Center	Phase 1/Phase 2
China Medical University Hospital	Phase 1/Phase 2
MedSIR	Phase 2

See all ERLOTINIB HYDROCHLORIDE clinical trials

Pharmacology for ERLOTINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for ERLOTINIB HYDROCHLORIDE

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERLOTINIB HYDROCHLORIDE

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ERLOTINIB HYDROCHLORIDE

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 ERLOTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	210300-003	Nov 5, 2019	AB	RX	No	No
Natco Pharma Ltd	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	208488-001	Nov 5, 2019		DISCN	No	No
Eugia Pharma	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	216342-003	Jun 22, 2022		DISCN	No	No
Accord Hlthcare	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211083-001	Jul 2, 2020		DISCN	No	No
Shilpa	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211960-001	Nov 5, 2019	AB	RX	No	No
Rising	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	091002-001	Jun 11, 2014	AB	RX	No	No
Shilpa	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211960-003	Nov 5, 2019	AB	RX	No	No

Expired US Patents for ERLOTINIB HYDROCHLORIDE

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	021743-002	Nov 18, 2004
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	021743-003	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004