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Generated: September 20, 2017
What is the patent landscape for Iressa, and what generic Iressa alternatives are available?
Iressa is a drug marketed by Astrazeneca Pharms and Astrazeneca and is included in two NDAs. There is one patent protecting this drug.| Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 105 |
| Clinical Trials: see list | 225 |
| Patent Applications: see list | 5,903 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | IRESSA at DailyMed |
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | IRESSA | gefitinib | TABLET;ORAL | 021399-001 | May 5, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Estonia | 9700252 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 0823900 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | H11504033 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 323066 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 0823900 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9603358 | ► Subscribe | |||||||||||||||||||||||||||
| Egypt | 24134 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 305444 | ► Subscribe | |||||||||||||||||||||||||||
| Luxembourg | 91631 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 9802839 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00429 | Netherlands | ► Subscribe | PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624 | ||||||||||||||||||||||||||
| C/GB09/059 | United Kingdom | ► Subscribe | PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624 | ||||||||||||||||||||||||||
| 90043-2.L | Sweden | ► Subscribe | PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302 | ||||||||||||||||||||||||||
| 631 | Luxembourg | ► Subscribe | 91631, EXPIRES: 20210423 | ||||||||||||||||||||||||||
| 2009009,C0823900 | Lithuania | ► Subscribe | PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624 | ||||||||||||||||||||||||||
| 2009 00051 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 7 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| C0065 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2009009 | Lithuania | ► Subscribe | PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624 | ||||||||||||||||||||||||||
| 3 | Finland | ► Subscribe | |||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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