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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Moodys
Merck
Covington
Fuji
US Army
Deloitte
Johnson and Johnson
McKinsey

Generated: February 19, 2018

DrugPatentWatch Database Preview

Afatinib dimaleate - Generic Drug Details

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What are the generic sources for afatinib dimaleate and what is the scope of afatinib dimaleate patent protection?

Afatinib dimaleate
is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Afatinib dimaleate has one hundred and sixty-four patent family members in forty-four countries.

There are six drug master file entries for afatinib dimaleate. One supplier is listed for this compound.
Summary for afatinib dimaleate
Pharmacology for afatinib dimaleate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for afatinib dimaleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Non-Orange Book US Patents for afatinib dimaleate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,404,697 Quinazoline derivatives for the treatment of cancer diseases ➤ Sign Up
8,586,608 Quinazoline derivatives and pharmaceutical compositions containing them ➤ Sign Up
9,089,571 Quinazoline derivatives for the treatment of cancer diseases ➤ Sign Up
7,019,012 Quinazoline derivatives and pharmaceutical compositions containing them ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for afatinib dimaleate

Country Document Number Estimated Expiration
New Zealand 589568 ➤ Sign Up
Mexico PA03005559 ➤ Sign Up
Denmark 1345910 ➤ Sign Up
Spain 2563211 ➤ Sign Up
Malaysia 151240 ➤ Sign Up
South Korea 101180752 ➤ Sign Up
Portugal 2508521 ➤ Sign Up
Austria 430136 ➤ Sign Up
Israel 209054 ➤ Sign Up
Cyprus 1117279 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for afatinib dimaleate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90011-2 Sweden ➤ Sign Up PRODUCT NAME: AFATINIB, TAUTOMERER, STEREOISOMERER OCH SALTER DAERAV, FYSIOLOGISKT GODTAGBARA SALTER MED OORGANISKA ELLER ORGANISKA SYROR ELLER BASER, SAERSKILT ETT MALEATSALT DAERAV, MER FOERETRAEDELSEVIS ETT DIMALEATSALT DAERAV; REG. NO/DATE: EU/1/13/879 20130925
14/009 Ireland ➤ Sign Up PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
2014 Austria ➤ Sign Up PRODUCT NAME: AFATINIB, DEREN TAUTOMERE, DEREN STEREOISOMERE UND DEREN SALZE, PHYSIOLOGISCH VERTRAEGLICHE SALZE MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, BEVORZUGT DEREN MALEATSALZE, VORZUGSWEISE DEREN DIMALEATSALZE; REGISTRATION NO/DATE: EU/1/13/879 20130925
2014 00006 Denmark ➤ Sign Up PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925
2014 00006 Denmark ➤ Sign Up PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925
2 Finland ➤ Sign Up
1345910/01 Switzerland ➤ Sign Up PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
C0009 France ➤ Sign Up PRODUCT NAME: AFATINIB,SES TAUTOMERES,SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES,EN PARTICULIER LE MALEATE OU LE DIMALEATE.; REGISTRATION NO/DATE: EU/1/13/879 20130925
2014005 Lithuania ➤ Sign Up PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
370 Luxembourg ➤ Sign Up PRODUCT NAME: AFATINIB,LES TAUTOMERES,LES STEREOISOMERES ET LES SELS DE CELUI-CI,DES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE CELUI-CI AVEC DES ACIDES OU BASES ORGANIQUES OU INORGANIQUES,DE PREFERENCE UN SEL MALEATE DE CELUI-CI,ET PLUS DE PREFERENCE UN SEL DIMALEATE DE CELUI-CI
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Johnson and Johnson
Baxter
Merck
Teva
Citi
Argus Health
Covington

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