ERLOTINIB HYDROCHLORIDE Drug Patent Profile

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Erlotinib Hydrochloride is a drug marketed by Accord Hlthcare, Alembic, Apotex, Eugia Pharma, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in ERLOTINIB HYDROCHLORIDE 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.

A generic version of ERLOTINIB HYDROCHLORIDE was approved as erlotinib hydrochloride by RISING on June 11^th, 2014.

US Patents:	0
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	830
Patent Applications:	19
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERLOTINIB HYDROCHLORIDE
DailyMed Link:	ERLOTINIB HYDROCHLORIDE at DailyMed

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Sponsor	Phase
MedSIR	Phase 2
Asan Medical Center	Phase 2
Boryung Pharmaceutical Co., Ltd	Phase 2

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Antineoplastic Agents
Protein Kinase Inhibitors

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARCEVA	Tablets	erlotinib hydrochloride	25 mg	021743	1	2008-11-18

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	213065-002	Apr 16, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa Inc	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	091059-001	Nov 9, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	213065-003	Apr 16, 2020	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa Inc	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	091059-002	Aug 28, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211083-001	Jul 2, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma Ltd	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	208488-003	Nov 5, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Shilpa	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211960-003	Nov 5, 2019	AB	RX	No	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