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GILOTRIF Drug Patent 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 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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Summary for GILOTRIF

International Patents:	186
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	16
Patent Applications:	666
Drug Prices:	Drug price information for GILOTRIF
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILOTRIF
What excipients (inactive ingredients) are in GILOTRIF?	GILOTRIF excipients list
DailyMed Link:	GILOTRIF at DailyMed

Drug patent expirations by year for GILOTRIF

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GILOTRIF

Generic Entry Date for GILOTRIF^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 201292 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

Sponsor	Phase
National Cancer Centre, Singapore	Phase 1
Vanderbilt-Ingram Cancer Center	Phase 1
Santosh Kesari	Phase 1

See all GILOTRIF clinical trials

Pharmacology for GILOTRIF

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GILOTRIF

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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

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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
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.

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Country	Patent Number	Title	Estimated Expiration
Croatia	P20131214		⤷ Sign Up
Chile	2010001275	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.	⤷ Sign Up
Hungary	E029863		⤷ Sign Up
Japan	2011522011		⤷ 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
Montenegro	02777	DERIVATI HINAZOLINA, LEKOVI KOII SADRŽE OVA JEDINJENJA, NJIHOVA PRIMENA I POSTUPAK ZA NJIHOVO PRIPREMANJE (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for GILOTRIF

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	C01345910/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
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
1345910	2014C/009	Belgium	⤷ Sign Up	PRODUCT NAME: AFATINIB ET SES TAUTOMERES, SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES, EN PARTICULIER, AFATINIB SOUS FORME DE SEL DE MALEATE OU DE DIMALEATE; AUTHORISATION NUMBER AND DATE: EU/1/13/879 20130927
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	C300643	Netherlands	⤷ Sign Up	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	⤷ 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for GILOTRIF

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GILOTRIF

Recent Clinical Trials for GILOTRIF

Pharmacology for GILOTRIF

Anatomical Therapeutic Chemical (ATC) Classes for GILOTRIF

Paragraph IV (Patent) Challenges for GILOTRIF

Patents protecting GILOTRIF

FDA Regulatory Exclusivity protecting GILOTRIF

When does loss-of-exclusivity occur for GILOTRIF?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GILOTRIF