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IRESSA Drug Profile
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This drug has forty-five patent family members in thirty-five countries.
The generic ingredient in IRESSA is gefitinib. There are seven 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 Tradename: IRESSA
| Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: IRESSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Clinical Trials for: IRESSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | RX | Yes | 5,770,599 | May 5, 2017 | Y | Y | ||||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | DISCN | No | 5,770,599 | May 5, 2017 | Y | Y | ||||||||||||||||||
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | RX | Yes | Jul 13, 2022 | |||||||||||||||||||||
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Expired Patents for Tradename: IRESSA
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | 5,457,105 | <disabled> | ||||||||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | 5,616,582 | <disabled> | ||||||||||||||||||||||
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International Patent Family for Tradename: IRESSA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Czech Republic | 9703396 | <disabled in preview> | |||||||||||||||||||||||||||
| Norway | 309472 | <disabled in preview> | |||||||||||||||||||||||||||
| Poland | 323066 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: IRESSA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7 | Finland | <disabled> | |||||||||||||||||||||||||||
| 09/039 | Ireland | <disabled> | 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 | ||||||||||||||||||||||||||
| 90043-2.L | Sweden | <disabled> | PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302 | ||||||||||||||||||||||||||
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information on patent expiries and potential generic entrants
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For information about when drugs will be coming off patent
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