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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
Drug Prices:see low prices

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 Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYes5,770,599May 5, 2017YY
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesJul 13, 2018
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesJul 13, 2022
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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
Australia699163<disabled in preview>
Denmark0823900<disabled in preview>
European Patent Office0823900<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
C/GB09/059United Kingdom<disabled>PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
3Finland<disabled>
00429Netherlands<disabled>PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
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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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