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Serving 500+ biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
Fish and Richardson
Deloitte
Argus Health
QuintilesIMS
Citi
AstraZeneca
McKesson
Queensland Health

Generated: July 21, 2017

DrugPatentWatch Database Preview

Gefitinib - Generic Drug Details

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What are the generic drug sources for gefitinib and what is the scope of gefitinib freedom to operate?

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

Gefitinib has forty-five patent family members in thirty-five countries.

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

Summary for Generic Name: gefitinib

Tradenames:1
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list105
Clinical Trials: see list331
Patent Applications: see list21,645
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gefitinib at DailyMed

Pharmacology for Ingredient: gefitinib

Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes5,770,599► SubscribeYY ► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003DISCNNoNo5,770,599► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 20035,616,582► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 20035,770,599► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 20155,770,599► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 20035,457,105► Subscribe
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International Patent Family for Ingredient: gefitinib

Country Document Number Estimated Expiration
JapanH11504033► Subscribe
Canada2215732► Subscribe
United Kingdom9508538► Subscribe
Japan3040486► Subscribe
Estonia9700252► 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 Certificates for Tradename: GEFITINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
631Luxembourg► Subscribe91631, EXPIRES: 20210423
3Finland► Subscribe
7Finland► Subscribe
2009009Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
00429Netherlands► SubscribePRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
QuintilesIMS
Teva
Accenture
Moodys
US Army
Farmers Insurance
Colorcon
Chinese Patent Office

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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