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IRESSA Drug Profile

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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. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.

Summary for IRESSA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	233
Patent Applications:	4,802
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for IRESSA

Constraining patent/regulatory exclusivity:

FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

NDA:

206995

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for IRESSA

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

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

See all IRESSA clinical trials

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

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		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	206995-001	Jul 13, 2015
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003

International Patents for IRESSA

Country	Patent Number	Estimated Expiration
Hungary	211311
Hungary	9802839
Denmark	0566226
Hungary	223313

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	403	Finland
0823900	CA 2009 00051	Denmark
0823900	PA2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624