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Generated: December 15, 2017

DrugPatentWatch Database Preview

GILOTRIF Drug Profile

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

Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-four patent family members in forty-four countries and twelve supplementary protection certificates in ten countries.

The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.

Summary for GILOTRIF

Drug patent expirations by year for GILOTRIF

Pharmacology for GILOTRIF

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

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
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimGILOTRIFafatinib dimaleateTABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for GILOTRIF

Drugname Dosage Strength RLD Submissiondate
afatinib dimaleateTablets20 mg, 30 mg and 40 mgGilotrif7/12/2017

Non-Orange Book Patents for Tradename: GILOTRIF

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 Tradename: GILOTRIF

Country Document Number Estimated Expiration
Portugal2508521► Subscribe
Spain2326617► Subscribe
Ukraine102549► Subscribe
Taiwan201000472► Subscribe
Peru02672010► Subscribe
Uruguay27078► Subscribe
Cyprus1117279► Subscribe
TaiwanI373470► Subscribe
European Patent Office2508521► Subscribe
China101402631► 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: GILOTRIF

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910/01Switzerland► SubscribePRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
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
2Finland► Subscribe
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
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
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
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
2014005,C1345910Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 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
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
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Serving leading biopharmaceutical companies globally:

Dow
Accenture
Citi
Boehringer Ingelheim
Harvard Business School
Healthtrust
Johnson and Johnson
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AstraZeneca
Fish and Richardson

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