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.
Summary for IRESSA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 141 |
Clinical Trials: | 233 |
Patent Applications: | 3,251 |
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 |


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
Sponsor | Phase |
---|---|
Beta Pharma, Inc. | Phase 3 |
Second Affiliated Hospital of Nanchang University | Phase 2 |
Nanchang University | Phase 2 |
Pharmacology for IRESSA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IRESSA
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 |