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IRESSA Drug Profile
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» See Plans and PricingWhen 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.
Summary for IRESSA
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 130 |
| Clinical Trials: | 233 |
| Patent Applications: | 5,317 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IRESSA |
| DailyMed Link: | IRESSA at DailyMed |
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 |
|---|---|
| Second Affiliated Hospital of Nanchang University | Phase 2 |
| Nanchang University | Phase 2 |
| Beta Pharma, Inc. | Phase 3 |
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 | 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 |
International Patents for IRESSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 436486 | Start Trial |
| Finland | 111631 | Start Trial |
| Slovakia | 1693 | Start Trial |
| Norway | 974940 | Start Trial |
| Hungary | 9300094 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
