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IRESSA Drug Profile

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Iressa is a drug marketed by Astrazeneca Pharms and Astrazeneca and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug.

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 list1
Drug Prices: :see details

Pharmacology for Tradename: IRESSA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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;ORAL206995-001Jul 13, 2015RXYes5,770,599May 5, 2017YY
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003DISCNNo5,770,599May 5, 2017YY
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesJul 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;ORAL021399-001May 5, 20035,457,105<disabled>
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 20035,616,582<disabled>
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International Patent Family for Tradename: IRESSA

Country Document Number Estimated Expiration
Czech Republic9703396<disabled in preview>
Norway309472<disabled in preview>
Poland323066<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
7Finland<disabled>
09/039Ireland<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.LSweden<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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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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