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Last Updated: June 28, 2022

IRESSA Drug Patent 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.

Drug patent expirations by year for IRESSA
Drug Prices for IRESSA

See drug prices for IRESSA

DrugPatentWatch® Estimated 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
Beta Pharma, Inc.Phase 3
Second Affiliated Hospital of Nanchang UniversityPhase 2
Nanchang UniversityPhase 2

See all IRESSA clinical trials

Pharmacology for IRESSA
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors

US Patents and Regulatory Information for IRESSA

IRESSA is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IRESSA is See Plans and Pricing.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting IRESSA

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
Exclusivity Expiration: See Plans and Pricing

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for IRESSA

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

Country Patent Number Title Estimated Expiration
Austria 198329 See Plans and Pricing
New Zealand 245662 QUINAZOLINE DERIVATIVES, PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF See Plans and Pricing
Hungary 221622 Kinazolinszármazékok, az ezeket tartalmazó gyógyászati készítmények és eljárás előállításukra (QUINAZOLINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS COMPRISING SAME AS ACTIVE INGREDIENT AND PROCESS FOR PRODUCING THEM) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IRESSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0823900 403 Finland See Plans and Pricing
0823900 CA 2009 00051 Denmark See Plans and Pricing
0823900 PA2009009,C0823900 Lithuania See Plans and Pricing PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
>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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.