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Serving leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Novartis
Chubb
Argus Health
Fish and Richardson
Daiichi Sankyo
Johnson and Johnson
McKinsey
Moodys

Generated: October 22, 2017

DrugPatentWatch Database Preview

GILOTRIF Drug Profile

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What is the patent landscape for Gilotrif, and what generic Gilotrif 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-three 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 Tradename: GILOTRIF

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list82
Clinical Trials: see list11
Patent Applications: see list3
Drug Prices:see details
DailyMed Link:GILOTRIF at DailyMed

Pharmacology for Tradename: GILOTRIF

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;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► SubscribeYY ► 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► Subscribe► 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► 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► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for GILOTRIF

Drugname Dosage Strength RLD Submissiondate
afatinib dimaleateTablets 20 mg, 30 mg and 40 mg Gilotrif7/12/2017

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
7,019,012Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
8,586,608Quinazoline 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
South Korea20120037987► Subscribe
Japan2009515851► Subscribe
Japan5264830► Subscribe
Japan5632367► Subscribe
Australia1917402► Subscribe
Argentina072062► Subscribe
Eurasian Patent Organization200300671► Subscribe
Serbia20060260► Subscribe
European Patent Office2299971► Subscribe
Poland361798► 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
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
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
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
2014005,C1345910Lithuania► 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
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
2Finland► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Harvard Business School
QuintilesIMS
Cipla
Covington
Novartis
Chinese Patent Office
Fuji
Healthtrust

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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