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Serving leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
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US Department of Justice
Covington
UBS
Cerilliant
Chubb
McKinsey
Healthtrust

Generated: December 15, 2017

DrugPatentWatch Database Preview

IRESSA Drug Profile

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When do Iressa patents expire, and what generic alternatives are available?

Iressa is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-five countries and eleven supplementary protection certificates in nine countries.

The generic ingredient in IRESSA is gefitinib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AstrazenecaIRESSAgefitinibTABLET;ORAL021399-001May 5, 2003DISCNNoNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsIRESSAgefitinibTABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsIRESSAgefitinibTABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsIRESSAgefitinibTABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: IRESSA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstrazenecaIRESSAgefitinibTABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
Astrazeneca PharmsIRESSAgefitinibTABLET;ORAL206995-001Jul 13, 2015► Subscribe► Subscribe
AstrazenecaIRESSAgefitinibTABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
AstrazenecaIRESSAgefitinibTABLET;ORAL021399-001May 5, 2003► Subscribe► Subscribe
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International Patent Family for Tradename: IRESSA

Country Document Number Estimated Expiration
Estonia03482► Subscribe
European Patent Office0823900► Subscribe
Bulgaria62730► Subscribe
Denmark0823900► Subscribe
Slovenia0823900► Subscribe
Australia699163► Subscribe
Germany69611361► Subscribe
Brazil9608082► Subscribe
Bulgaria102052► Subscribe
Romania117849► 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
C/GB09/059United Kingdom► SubscribePRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
3Finland► Subscribe
2009009Lithuania► SubscribePRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
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
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
2009 00051Denmark► 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
7Finland► Subscribe
00429Netherlands► SubscribePRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
631Luxembourg► Subscribe91631, EXPIRES: 20210423
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Dow
McKinsey
Chubb
Accenture
Healthtrust
Argus Health
Daiichi Sankyo
Express Scripts

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