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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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McKinsey
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Generated: September 20, 2017

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 fifty 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 Generic Name: afatinib dimaleate

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Bulk Api Vendors: see list14
Clinical Trials: see list118
Patent Applications: see list3
Drug Prices:see low prices
DailyMed Link:afatinib dimaleate at DailyMed

Pharmacology for Ingredient: 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;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► SubscribeY ► 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► SubscribeYY ► 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
7,019,012Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
9,089,571Quinazoline derivatives for the treatment of cancer diseases► Subscribe
8,404,697Quinazoline derivatives for the treatment of cancer diseases► Subscribe
8,586,608Quinazoline derivatives and pharmaceutical compositions containing them► 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
Hungary0301852► Subscribe
Brazil0116266► Subscribe
Israel209054► Subscribe
European Patent Office1948179► Subscribe
Canada2833852► Subscribe
Austria430136► Subscribe
Australia2009254574► Subscribe
Morocco34030► Subscribe
Japan2004516283► Subscribe
Spain2563211► 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
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
14/009Ireland► SubscribePRODUCT 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
1345910/01Switzerland► SubscribePRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
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
00643Netherlands► SubscribePRODUCT NAME: AFATINIB, DE TAUTOMEREN, STEREOISOMEREN EN ZOUTEN DAARVAN, IN HET BIJZONDER FYSIOLOGISCH AANVAARDBARE ZOUTEN MET ANORGANISCHE OF ORGANISCHE ZUREN OF BASEN, MEER IN HET BIJZONDER ZOUTEN MET MALEINEZUUR, MET NAME EEN DIMALEAATZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
2014005Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 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
2014005,C1345910Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Cipla
Farmers Insurance
Citi
Teva
Chinese Patent Office
Federal Trade Commission
Dow
Express Scripts
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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