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Serving 500+ biopharmaceutical companies globally:

Julphar
Express Scripts
US Department of Justice
Teva
AstraZeneca
Farmers Insurance
Daiichi Sankyo
Fish and Richardson
Citi
Cipla

Generated: September 20, 2017

DrugPatentWatch Database Preview

IRESSA Drug Profile

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What is the patent landscape for Iressa, and what generic Iressa alternatives are available?

Iressa is a drug marketed by Astrazeneca Pharms and Astrazeneca and is included in two NDAs. 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 nine 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
Bulk Api Vendors: see list105
Clinical Trials: see list225
Patent Applications: see list5,903
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:IRESSA at DailyMed

Pharmacology for Tradename: IRESSA

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► SubscribeYY ► Subscribe
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► Subscribe► Subscribe
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Expired Patents for Tradename: IRESSA

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
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International Patent Family for Tradename: IRESSA

Country Document Number Estimated Expiration
Estonia9700252► Subscribe
Slovenia0823900► Subscribe
JapanH11504033► Subscribe
Poland323066► Subscribe
Denmark0823900► Subscribe
South Africa9603358► Subscribe
Egypt24134► Subscribe
New Zealand305444► Subscribe
Luxembourg91631► Subscribe
Hungary9802839► 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: IRESSA

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
C/GB09/059United Kingdom► SubscribePRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
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
631Luxembourg► Subscribe91631, EXPIRES: 20210423
2009009,C0823900Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
2009 00051Denmark► Subscribe
7Finland► Subscribe
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
2009009Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
3Finland► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Harvard Business School
Fuji
Dow
Novartis
Cantor Fitzgerald
Julphar
US Army
Argus 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.

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