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Gefitinib - Generic Drug Details

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Gefitinib is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and Astrazeneca, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-five patent family members in thirty-five countries.

There are seven drug master file entries for gefitinib. One supplier is listed for this compound.

Summary for Generic Name: gefitinib

Tradenames:1
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packaging: see list1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: gefitinib

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003DISCNNo5,770,599<disabled>YY <disabled>
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYes<disabled><disabled>
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: gefitinib

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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 Ingredient: gefitinib

Country Document Number Estimated Expiration
Germany122009000076<disabled in preview>
Israel118045<disabled in preview>
Spain2153098<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: GEFITINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2009009,C0823900Lithuania<disabled>PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
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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