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Last Updated: January 31, 2023

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 Generic Entry Opportunity 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 Action Protein 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 six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GILOTRIF is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing amino crotonyl compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid pharmaceutical formulations comprising BIBW 2992
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Quinazoline derivatives for the treatment of cancer diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Quinazoline derivatives and pharmaceutical compositions containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting GILOTRIF

TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTSFROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 201292-003 Jul 12, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 201292-003 Jul 12, 2013 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 09254574
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0913379
Estimated Expiration: See Plans and Pricing

Canada

Patent: 26472
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10001275
Estimated Expiration: See Plans and Pricing

China

Patent: 2056589
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80463
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161061
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17895
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 99971
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010650
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2168
Estimated Expiration: See Plans and Pricing

Patent: 1001852
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99971
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 52478
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29863
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9054
Estimated Expiration: See Plans and Pricing

Japan

Patent: 32367
Estimated Expiration: See Plans and Pricing

Patent: 11522011
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1240
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10012939
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 478
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 030
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9568
Estimated Expiration: See Plans and Pricing

Peru

Patent: 100252
Estimated Expiration: See Plans and Pricing

Poland

Patent: 99971
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 99971
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 943
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 99971
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1007805
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1641517
Estimated Expiration: See Plans and Pricing

Patent: 110025908
Estimated Expiration: See Plans and Pricing

Spain

Patent: 88031
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 53203
Estimated Expiration: See Plans and Pricing

Patent: 1000472
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000557
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2549
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 867
Estimated Expiration: See Plans and Pricing

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
Portugal 2508521 See Plans and Pricing
Bulgaria 66139 See Plans and Pricing
Malaysia 149921 PROCESS FOR PREPARING AMINO CROTONYL COMPOUNDS See Plans and Pricing
Montenegro P50808 POSTUPAK ZA DOBIJANJE AMINO KROTONILNIH JEDINJENJA (METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS) See Plans and Pricing
Ukraine 91006 СПОСОБ ПОЛУЧЕНИЯ АМИНОКРОТОНИЛЬНЫХ СОЕДИНЕНИЙ;СПОСІБ ОДЕРЖАННЯ АМІНОКРОТОНІЛЬНИХ СПОЛУК (METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS) See Plans and Pricing
Uruguay 27078 DERIVADOS DE QUINAZOLINA, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS, SU EMPLEO Y PROCEDIMENTOS PARA SU PREPARACIÓN See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILOTRIF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910 CR 2014 00006 Denmark See Plans and Pricing 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
1345910 PA2014005,C1345910 Lithuania See Plans and Pricing PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 C300643 Netherlands See Plans and Pricing PRODUCT 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
1345910 2014/009 Ireland See Plans and Pricing 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 Lithuania See Plans and Pricing PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 1490011-2 Sweden See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Baxter
Johnson and Johnson
Harvard Business School
Merck

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.