.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Dow
US Army
Mallinckrodt
AstraZeneca
Harvard Business School
QuintilesIMS
Teva
Moodys
Citi

Generated: September 25, 2017

DrugPatentWatch Database Preview

Gefitinib - Generic Drug Details

« Back to Dashboard

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 is one patent 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:1
Applicants:2
NDAs:2
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list105
Clinical Trials: see list335
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
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015► Subscribe► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
Astrazeneca
IRESSA
gefitinib
TABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: gefitinib

Country Document Number Estimated Expiration
Bulgaria62730► Subscribe
Bulgaria102052► Subscribe
South Africa9603358► Subscribe
Norway974940► Subscribe
China1182421► Subscribe
Israel118045► Subscribe
Australia699163► Subscribe
Portugal823900► Subscribe
New Zealand305444► Subscribe
Argentina003944► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: GEFITINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00429Netherlands► SubscribePRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
2009009,C0823900Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
C0065France► SubscribePRODUCT 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► Subscribe91631, EXPIRES: 20210423
09/039Ireland► SubscribePRODUCT 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
C/GB09/059United Kingdom► SubscribePRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
7Finland► Subscribe
90043-2.LSweden► SubscribePRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302
2009009Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
3Finland► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
Cipla
Boehringer Ingelheim
Deloitte
Colorcon
AstraZeneca
Dow
Moodys
Covington
Queensland Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot