GEFITINIB - Generic Drug Details

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What are the generic sources for gefitinib and what is the scope of freedom to operate?

Gefitinib is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, Natco, Qilu Pharm Hainan, and Astrazeneca, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for gefitinib. Six suppliers are listed for this compound.

Summary for GEFITINIB

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	386
Patent Applications:	7,285
Drug Prices:	Drug price trends for GEFITINIB
What excipients (inactive ingredients) are in GEFITINIB?	GEFITINIB excipients list
DailyMed Link:	GEFITINIB at DailyMed

See drug prices for GEFITINIB

Recent Clinical Trials for GEFITINIB

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

Sponsor	Phase
China Medical University Hospital	Phase 1/Phase 2
Daiichi Sankyo, Inc.	Phase 2
MedSIR	Phase 2

See all GEFITINIB clinical trials

Pharmacology for GEFITINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GEFITINIB

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

US Patents and Regulatory Information for GEFITINIB

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Glossary

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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
Actavis Labs Fl Inc	GEFITINIB	gefitinib	TABLET;ORAL	208913-001	Apr 26, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco	GEFITINIB	gefitinib	TABLET;ORAL	212827-001	May 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu Pharm Hainan	GEFITINIB	gefitinib	TABLET;ORAL	211591-001	Feb 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	AB	RX	Yes	Yes	⤷ 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 GEFITINIB

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	⤷ Sign Up	⤷ Sign Up
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for GEFITINIB

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Gefitinib Mylan	gefitinib	EMEA/H/C/004826 Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.	Authorised	yes	no	no	2018-09-27
AstraZeneca AB	Iressa	gefitinib	EMEA/H/C/001016 Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.	Authorised	no	no	no	2009-06-24
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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