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Last Updated: July 5, 2020

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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 Astrazeneca Pharms 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.

Drug patent expirations by year for IRESSA
Drug Prices for IRESSA

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Generic Entry Opportunity Date for IRESSA
Generic Entry 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:
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

SponsorPhase
Second Affiliated Hospital of Nanchang UniversityPhase 2
Nanchang UniversityPhase 2
Beta Pharma, Inc.Phase 3

See all IRESSA clinical trials

Pharmacology for IRESSA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 IRESSA

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

Supplementary Protection Certificates for IRESSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0823900 SPC/GB09/059 United Kingdom   Start Trial PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
0823900 CA 2009 00051 Denmark   Start Trial
0823900 91631 Luxembourg   Start Trial 91631, EXPIRES: 20210423
0823900 PA2009009,C0823900 Lithuania   Start Trial PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900 C300429 Netherlands   Start Trial PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Express Scripts
Merck
Harvard Business School
Johnson and Johnson

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