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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Healthtrust
UBS
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Chinese Patent Office
Julphar
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Generated: November 21, 2017

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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-three patent family members in forty-four countries and twelve supplementary protection certificates in ten 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
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;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,404,697Quinazoline derivatives for the treatment of cancer diseases► Subscribe
8,586,608Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
7,019,012Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
9,089,571Quinazoline derivatives for the treatment of cancer diseases► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: afatinib dimaleate

Country Document Number Estimated Expiration
Eurasian Patent Organization200600604► Subscribe
Serbia54943► Subscribe
Denmark2299971► Subscribe
New Zealand526918► Subscribe
Norway2014003► Subscribe
Japan2011522011► Subscribe
MontenegroP50808► Subscribe
TaiwanI295992► Subscribe
CroatiaP20131214► Subscribe
Singapore139743► 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: AFATINIB DIMALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009France► SubscribePRODUCT 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
2Finland► Subscribe
90011-2Sweden► SubscribePRODUCT 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
370Luxembourg► SubscribePRODUCT 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
2014 00006Denmark► SubscribePRODUCT 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 00006Denmark► SubscribePRODUCT 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
2014005Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
2014Austria► SubscribePRODUCT 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
1345910/01Switzerland► SubscribePRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
2014005,C1345910Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
McKesson
Chubb
McKinsey
Baxter
Cerilliant
Colorcon
Harvard Business School
Dow
Farmers Insurance

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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