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Last Updated: July 23, 2024

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GILOTRIF Drug Patent Profile


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Which patents cover Gilotrif, and when can generic versions of Gilotrif launch?

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 eighty-seven patent family members in forty-six 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.

DrugPatentWatch® Generic Entry Outlook for Gilotrif

Gilotrif was eligible for patent challenges on July 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2030. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for GILOTRIF
Drug Prices for GILOTRIF

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GILOTRIF
Generic Entry Date for GILOTRIF*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GILOTRIF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National University Hospital, SingaporePhase 2
National Cancer Centre, SingaporePhase 1
Vanderbilt-Ingram Cancer CenterPhase 1

See all GILOTRIF clinical trials

Pharmacology for GILOTRIF
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for GILOTRIF
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GILOTRIF Tablets afatinib dimaleate 20 mg, 30 mg and 40 mg 201292 7 2017-07-12

US Patents and Regulatory Information for GILOTRIF

GILOTRIF is protected by five US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GILOTRIF is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting GILOTRIF

Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Process for preparing amino crotonyl compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid pharmaceutical formulations comprising BIBW 2992
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Quinazoline derivatives for the treatment of cancer diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Quinazoline derivatives and pharmaceutical compositions containing them
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting GILOTRIF

FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 201292-001 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 201292-003 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 201292-001 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 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

Expired US Patents for GILOTRIF

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GILOTRIF

When does loss-of-exclusivity occur for GILOTRIF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2062
Patent: FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN BIBW 2992
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09254574
Patent: Solid pharmaceutical formulations comprising BIBW 2992
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0913379
Patent: formulações farmacêuticas sólidas compreendendo bibw 2992
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 26472
Patent: FORMULATIONS PHARMACEUTIQUES SOLIDES COMPRENANT DU BIBW 2992 (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 10001275
Patent: Metodo para producir un producto intermedio compactado de bibw 2992 ma2 que comprende una etapa de compactacion por rodillos de bibw 2992 ma2 u opcionalmente en una premezcla con 0-1,0% de lubricante en un mezclador de caida libre o de volteo y una etapa de tamizado; producto intermedio compactado; comprimido.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2056589
Patent: Solid pharmaceutical formulations comprising BIBW 2992
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80463
Patent: FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN BIBW 2992
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0161061
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17895
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010650
Patent: FORMULACIONES FARMACÉUTICAS SÓLIDAS QUE COMPRENDEN BIBW 2992.
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2168
Patent: СПОСОБ ПОЛУЧЕНИЯ УПЛОТНЕННОГО ПРОМЕЖУТОЧНОГО ПРОДУКТА ДИМАЛЕАТА BIBW 2992 И ТВЕРДЫЕ ТАБЛЕТКИ, ПОЛУЧЕННЫЕ ИЗ ТАКОГО ПРОДУКТА (METHOD FOR PRODUCTION OF COMPACTED INTERMEDIATE DIMALEATE BIBW 2992 AND SOLID TABLETS PREPARED FROM SUCH INTERMEDIATE)
Estimated Expiration: ⤷  Sign Up

Patent: 1001852
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ BIBW 2992
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 99971
Patent: FORMULATIONS PHARMACEUTIQUES SOLIDES COMPRENANT DU BIBW 2992 (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 52478
Patent: SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 29863
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9054
Patent: שיטה לייצור חומר ביניים דחוס של 2992 bibw, חומר ביניים דחוס זה והרכבי רוקחות מוצקים המכילים חומר ביניים דחוס זה (Method of producing a compacted intermediate of bibw 2992, such compacted intermediate and solid pharmaceutical formulations comprising said compacted intermediate)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 32367
Estimated Expiration: ⤷  Sign Up

Patent: 11522011
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1240
Patent: SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10012939
Patent: FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN BIBW 2992. (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 478
Patent: ČVRSTE FARMACEUTSKE FORMULACIJE KOJE SADRŽE BIBW 2992 (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 030
Patent: Formulations pharmaceutiques solides comprenant du bibw 2992
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9568
Patent: Compacted formulations comprising 4-[(3-chloro-4-fluorophenyl)amino-6-{ [4-(N,N-dimethylamino)-1-oxo-2-buten-1-yl]amino} -7-((S)-tetrahydrofuran-3-yloxy)-quinazoline dimaleate (BIBW 2992 dimaleate)
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 100252
Patent: NUEVAS FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN DIMALEATO DE 4-[(3-CLORO-4-FLUOROFENIL) AMINO]-6-{[4-(N,N-DIMETILAMINO)-1-OXO-2-BUTEN-1-IL] AMINO}-7-((S)-TETRAHIDROFURAN-3-ILOXI)-QUINAZOLINA
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 943
Patent: ČVRSTE FARMACEUTSKE FORMULACIJE KOJE SADRŽE BIBW 2992 (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 99971
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1007805
Patent: SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1641517
Estimated Expiration: ⤷  Sign Up

Patent: 110025908
Patent: SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 88031
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53203
Estimated Expiration: ⤷  Sign Up

Patent: 1000472
Patent: New solid pharmaceutical formulations comprising BIBW 2992
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000557
Patent: SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 2549
Patent: СПОСОБ ПОЛУЧЕНИЯ УПЛОТНЕННОГО ПРОМЕЖУТОЧНОГО ПРОДУКТА ДИМАЛЕАТА BIBW 2992, УПЛОТНЕННЫЙ ПРОМЕЖУТОЧНЫЙ ПРОДУКТ И ТВЕРДАЯ ПЕРОРАЛЬНАЯ ТАБЛЕТКА;СПОСІБ ОДЕРЖАННЯ УЩІЛЬНЕНОГО ПРОМІЖНОГО ПРОДУКТУ ДИМАЛЕАТУ BIBW 2992, УЩІЛЬНЕНИЙ ПРОМІЖНИЙ ПРОДУКТ ТА ТВЕРДА ПЕРОРАЛЬНА ТАБЛЕТКА (PROCESS FOR THE PREPARATION OF COMPACTED INTERMEDIATE COMPRISING BIBW 2992 DIMALEATE, COMPACTED INTERMEDIATE AND SOLID DOSAGE FORM)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 867
Patent: NUEVAS FORMULACIONES FARMACÉUTICAS SÓLIDAS QUE COMPRENDEN BIBW 2992
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GILOTRIF around the world.

Country Patent Number Title Estimated Expiration
South Africa 200602234 Method for the production of amino crotonyl compounds ⤷  Sign Up
Australia 1917402 ⤷  Sign Up
South Korea 100852102 ⤷  Sign Up
South Korea 101180752 ⤷  Sign Up
Malaysia 151240 SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992 ⤷  Sign Up
Brazil 122013033343 dimaleato de 4-[(3-cloro-4-fluorfenil)amino]-6-{[4-(n,n-dimetilamino)-1-oxo-2-buten-1-il]amino}-7-((s)-tetraidrofuran-3-ilóxi)-quinazolina, seu uso e seu processo de preparação, e composições farmacêuticas ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILOTRIF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910 PA2014005 Lithuania ⤷  Sign Up PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 2014/009 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
1345910 PA2014005,C1345910 Lithuania ⤷  Sign Up PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 132014902231089 Italy ⤷  Sign Up PRODUCT NAME: AFATINIB, SUOI TAUTOMERI, STEREOISOMERI E SALI, SALI FISIOLOGICAMENTE ACCETTABILI CON ACIDI O BASI INORGANICI O ORGANICI, PREFERIBILMENTE UN SUO SALE MALEATO, PIU' PREFERIBILMENTE UN SUO SALE DIMALEATO(GIOTRIF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/879, 20130925
1345910 452 Finland ⤷  Sign Up
1345910 CA 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.