IRESSA Drug Patent Profile

When do Iressa patents expire, and when can generic versions of Iressa launch?

Iressa is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iressa

A generic version of IRESSA was approved as gefitinib by APOTEX on September 23^rd, 2022.

Summary for IRESSA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	233
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IRESSA
What excipients (inactive ingredients) are in IRESSA?	IRESSA excipients list
DailyMed Link:	IRESSA at DailyMed

See drug prices for IRESSA

Recent Clinical Trials for IRESSA

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

Sponsor	Phase
Beta Pharma, Inc.	Phase 3
Second Affiliated Hospital of Nanchang University	Phase 2
Nanchang University	Phase 2

See all IRESSA clinical trials

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IRESSA

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 IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	AB	RX	Yes	Yes

Expired US Patents for IRESSA

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

EU/EMA Drug Approvals for IRESSA

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

International Patents for IRESSA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2215732	DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES)
New Zealand	245662	QUINAZOLINE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF
Finland	930208

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	0990043-2.L	Sweden		PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302
0823900	PA2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	403	Finland