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Serving leading biopharmaceutical companies globally:

Cerilliant
Dow
US Army
Healthtrust
Express Scripts
Baxter
Queensland Health
Merck
Citi
Medtronic

Generated: January 18, 2018

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 and Astrazeneca Pharms, 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-seven patent family members in thirty-five countries.

There are eleven drug master file entries for gefitinib. One supplier is listed for this compound.
Pharmacology for gefitinib
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for gefitinib

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;ORAL 206995-001 Jul 13, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 DISCN No No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Astrazeneca Pharms IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 ➤ Subscribe ➤ Subscribe
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for gefitinib

Supplementary Protection Certificates for gefitinib

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00051 Denmark ➤ Subscribe
2009009,C0823900 Lithuania ➤ Subscribe PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
2009009 Lithuania ➤ Subscribe PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
3 Finland ➤ Subscribe
00429 Netherlands ➤ Subscribe PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
C/GB09/059 United Kingdom ➤ Subscribe PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624
C0065 France ➤ Subscribe PRODUCT 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
631 Luxembourg ➤ Subscribe 91631, EXPIRES: 20210423
7 Finland ➤ Subscribe
90043-2.L Sweden ➤ Subscribe PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Cerilliant
Federal Trade Commission
Johnson and Johnson
Fuji
Healthtrust
Deloitte
Colorcon
Cantor Fitzgerald

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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