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. 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 23rd, 2022.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for IRESSA?
- What are the global sales for IRESSA?
- What is Average Wholesale Price for IRESSA?
Summary for IRESSA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 155 |
Clinical Trials: | 233 |
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 |
![IRESSA drug patent expirations Drug patent expirations by year for IRESSA](/p/graph/s/t/IRESSA-patent-expirations.png)
![Drug Prices for IRESSA](/p/graph/drug-price/IRESSA.png)
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Japan | 3040486 | ⤷ Sign Up | |
Slovenia | 0823900 | ⤷ Sign Up | |
Israel | 118045 | ⤷ Sign Up | |
Argentina | 003944 | DERIVADOS DE QUINAZOLINA, SAL DE HIDROCLORURO, PROCESO PARA LA PREPARACION, COMPOSICION FARMACEUTICA QUE LO CONTIENE Y SU UTILIZACION | ⤷ Sign Up |
Norway | 930178 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IRESSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0823900 | 0990043-2.L | Sweden | ⤷ Sign Up | PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302 |
0823900 | 91631 | Luxembourg | ⤷ Sign Up | 91631, EXPIRES: 20210423 |
0823900 | 2009/039 | Ireland | ⤷ Sign Up | 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 | CA 2009 00051 | Denmark | ⤷ Sign Up | |
0823900 | 09C0065 | France | ⤷ Sign Up | PRODUCT NAME: GEFITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/09/526/001 20090624; FIRST REGISTRATION: CH - 56154 20040302 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |