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Last Updated: May 29, 2024

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GILOTRIF Drug Patent Profile


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Which patents cover Gilotrif, 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 eighty-six 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

See drug prices for GILOTRIF

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 Cancer Centre, SingaporePhase 1
Vanderbilt-Ingram Cancer CenterPhase 1
Santosh KesariPhase 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 201292-002 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09254574
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0913379
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 26472
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 10001275
Estimated Expiration: ⤷  Sign Up

China

Patent: 2056589
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80463
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
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2168
Estimated Expiration: ⤷  Sign Up

Patent: 1001852
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 52478
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 29863
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9054
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 32367
Estimated Expiration: ⤷  Sign Up

Patent: 11522011
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1240
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10012939
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 478
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 030
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9568
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 100252
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 99971
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 943
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 99971
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1007805
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1641517
Estimated Expiration: ⤷  Sign Up

Patent: 110025908
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 88031
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53203
Estimated Expiration: ⤷  Sign Up

Patent: 1000472
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000557
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 2549
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 867
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
Japan 2004516283 ⤷  Sign Up
Ukraine 102549 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) ⤷  Sign Up
Taiwan I453203 ⤷  Sign Up
Estonia 05244 Kinasoliinderivaadid, neid hendeid sisaldavad ravimid, nende kasutamine ja meetod nende valmistamiseks ⤷  Sign Up
Colombia 6280463 FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN BIBW 2992 ⤷  Sign Up
Spain 2326617 ⤷  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 1490011-2 Sweden ⤷  Sign Up PRODUCT 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
1345910 PA2014005 Lithuania ⤷  Sign Up PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 SPC/GB14/015 United Kingdom ⤷  Sign Up PRODUCT NAME: AFATINIB, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, IN PARTICULAR A SALT WITH MALEIC ACID; REGISTERED: UK EU/1/13/879/001 20130927; UK EU/1/13/879/002 20130927; UK EU/1/13/879/003 20130927; UK EU/1/13/879/004 20130927; UK EU/1/13/879/005 20130927; UK EU/1/13/879/006 20130927; UK EU/1/13/879/007 20130927; UK EU/1/13/879/008 20130927; UK EU/1/13/879/009 20130927; UK EU/1/13/879/010 20130927; UK EU/1/13/879/011 20130927; UK EU/1/13/879/012 20130927
1345910 14C0009 France ⤷  Sign Up PRODUCT 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
1345910 452 Finland ⤷  Sign Up
1345910 122014000016 Germany ⤷  Sign Up PRODUCT NAME: AFATINIB, DIE TAUTOMEREN, DIE STEREOISOMEREN UND DIE SALZE DAVON, INSBESONDERE PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, INSBESONDERE SALZE MIT MALEINSAEURE; REGISTRATION NO/DATE: EU/1/13/879/001-012 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.