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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

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, 2015RXYes5,770,599<disabled>YY <disabled>
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003DISCNNo5,770,599<disabled>YY <disabled>
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYes<disabled><disabled>
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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
China1100046<disabled in preview>
Czech Republic288489<disabled in preview>
Canada2215732<disabled in preview>
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Supplementary Protection Certificates for Tradename: IRESSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0065France<disabled>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
631Luxembourg<disabled>91631, EXPIRES: 20210423
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