GILOTRIF Drug Patent Profile

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

Summary for GILOTRIF

International Patents:	186
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	16
Patent Applications:	862
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

See drug prices for GILOTRIF

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for GILOTRIF

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 six FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting GILOTRIF

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
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No					Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No

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
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Bulgaria	66139
Malaysia	149921	PROCESS FOR PREPARING AMINO CROTONYL COMPOUNDS
Montenegro	P50808	POSTUPAK ZA DOBIJANJE AMINO KROTONILNIH JEDINJENJA (METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS)
Ukraine	91006	СПОСОБ ПОЛУЧЕНИЯ АМИНОКРОТОНИЛЬНЫХ СОЕДИНЕНИЙ;СПОСІБ ОДЕРЖАННЯ АМІНОКРОТОНІЛЬНИХ СПОЛУК (METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS)
Uruguay	27078	DERIVADOS DE QUINAZOLINA, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS, SU EMPLEO Y PROCEDIMENTOS PARA SU PREPARACIÓN

Supplementary Protection Certificates for GILOTRIF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	CR 2014 00006	Denmark		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		PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910	C300643	Netherlands		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		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		PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910	1490011-2	Sweden		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