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:	155
Clinical Trials:	233
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
Nanchang University	Phase 2
Second Affiliated Hospital of Nanchang University	Phase 2

See all IRESSA clinical trials

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

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
Romania	117849	DERIVATI DE CHINAZOLINA, PROCEDEU DE PREPARARE A ACESTORA, COMPOZITIE FARMACEUTICA SI METODA DE PRODUCERE A UNUI EFECT ANTIPROLIFERATIV (QUINAZOLINE DERIVATIVES, PROCESS OF PREPARING THE SAME, PHARMACEUTICAL COMPOSITION AND METHOD OF PRODUCING AN ANTI-PROLIFERATIVE EFFECT)
Denmark	0566226
Slovakia	282236

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	2009/039	Ireland		PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE MONO- OR DI- ACID-ADDITION SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/09/526/001 20090624; FIRST REGISTRATION NO/DATE: 56154 01 20040302
0823900	C300429	Netherlands		PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
0823900	347	Finland