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GILOTRIF Drug 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 sixty-four patent family members in forty-four 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.

Summary for GILOTRIF

International Patents:	164
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	128
Clinical Trials:	11
Patent Applications:	14
Drug Prices:	Drug price information for GILOTRIF
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILOTRIF
DailyMed Link:	GILOTRIF at DailyMed

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.

Pharmacology for GILOTRIF

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for GILOTRIF

(2e)-n-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3s)-tetrahydro-3-furanyl)oxy)-6-quinazolinyl)-4-(dimethylamino)-2-butenamide

(2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)

(2E)-N-(4-(3-chloro-4-fluoroanilino)-7-(((3S)-oxolan-3-yl)oxy)quinoxazolin-6-yl)-4-(dimethylamino)but-2-enamide

(2E)-N-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3S

(2E)-N-[4-(3-Chloro-4-fluoroanilino)-7-[[(3S)-oxolane-3-yl]oxy]quinazoline-6-yl]-4-(dimethylamino)-2-buteneamide

(2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-oxolan-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide

(2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-tetrahydrofuran-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide

(2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-tetrahydrofuran-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide di[(2Z)-but-2-enedioate]

(E)-4-Dimethylamino-But-2-Enoic Acid-(4-(3-Chloro-4-Fluoro-Phenylamino)-7-((S)-Tetra-Hydrofuran-3-Yloxy)-Quinazolin-6Yl)-Amide Dimaleate

(E)-4-dimethylamino-but-2-enoic acid-(4-(3-chloro-4-fluoro-phenylamino)-7-((S)-tetrahydrofuran-3-yloxy)-quinazolin-6-yl)-amide

(E)-4-dimethylamino-but-2-enoic acid-(4-(3-chloro-4-fluoro-phenylamino)-7-((S)-tetrahydrofuran-3-yloxy)-quinazolin-6yl)-amide

(E)-4-Dimethylamino-but-2-enoic acid-[4-(3-chloro-4-fluoro-phenylamino)-7-((S)-tetrahydrofuran-3-yloxy)-quinazolin-6-yl]-amide

(E)-N-[4-(3-chloro-4-fluoro-anilino)-7-[(3S)-tetrahydrofuran-3-yl]oxy-quinazolin-6-yl]-4-(dimethylamino)but-2-enamide

(R,E)-N-(4-(3-chloro-4-fluorophenylamino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide

(S,E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide

(S,E)-N-(4-(3-chloro-4-fluorophenylamino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide

(S)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide

(S)-N-(4-(3-chloro-4-fluorophenylamino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide

(Z)-but-2-enedioic acid;(E)-N-[4-(3-chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide

081B182

2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydro-3-furanyl)oxy)- 6-quinazolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:2)

2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydro-3-furanyl)oxy)-6-quinazolinyl)-4-(dimethylamino)-

2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydro-3-furanyl)oxy)-6-quinazolinyl)-4-(dimethylamino)-, (2E)-

2-Butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino

2-BUTENAMIDE, N-[4-[(3-CHLORO-4-FLUOROPHENYL)AMINO]-7-[[(3S)-TETRAHYDRO-3-FURANYL]OXY]-6-QUINAZOLINYL]-4-(DIMETHYLAMINO)-

2-Butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-, (2E)-

3123AC

41UD74L59M

439081-18-2

6-Acetyl-8-cyclopentyl-5-methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]pyrido[2,3-d]pyrimidin-7(8H)-one 2-hydroxy-ethanesulfonic acid (1:1)

850140-72-6

850140-73-7

915958-11-1

A15572

AB0033685

AB01565886_02

ABP000859

AC-26079

AC-26080

AC-27018

ACN-043929

Afatinib

Afatinib (BIBW2992)

Afatinib (diMaleate)

Afatinib (USAN/INN)

Afatinib [USAN:INN]

AFATINIB DIMALEATE

Afatinib dimaleate (USAN)

Afatinib dimaleate [USAN]

Afatinib maleate

Afatinib maleate (JAN)

afatinibum

AJ-47553

AK-43479

AK109009

AKOS015850681

AKOS015904219

AKOS025149636

AKOS025401819

AM808098

AMX10177

AN-537

AOB87350

AOB87785

AX8164181

AX8210970

BCP9000407

BCPP000338

BDBM50322823

BIBW 2992

BIBW 2992MA2

BIBW-2992

BIBW2992

BIBW2992 - Afatinib

BIBW2992 MA2

BIBW2992,Afatinib

BIBW2992/Tovok,BIBW-2992

BIFK0010

BRD-K66175015-001-01-7

C24H25ClFN5O3

CHEBI:61390

CHEBI:76003

CHEBI:94698

CHEMBL1173655

CHEMBL2105712

CS-1329

D05UFG

D09724

D09733

DB08916

EGFR inhibitor 2nd gens

EX-8656

EX-A065

FT-0083487

Gilotrif (TN)

Giotrif

Giotrif (TN)

GTPL5667

HY-10261A

I14-17009

J-500781

J-502300

KB-333876

KB-47976

KB-74529

MFCD12407405

MLS006010000

MolPort-009-679-394

MolPort-028-744-902

N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3''S'')-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4(dimethylamino)-2-butenamide

N-[4-[(3-CHLORO-4-FLUOROPHENYL)AMINO]-7-[[(3S)-TETRAHYDRO-3-FURANYL]OXY]-6-QUINAZOLINYL]-4-(DIMETHYL 2-BUTENAMIDE]

N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-Butenamide

NCGC00185000-01

NSC-750691

NSC750691

PB28439

PubChem22403

Q-3651

QC-11139

QCR-169

RL05240

S1011

SC-66830

SC-87772

SC-87788

SMR004701084

SR-01000941576

SR-01000941576-1

ST24036355

TC-162525

TC-163608

Tomtovok

Tovok

Tovok (TN)

Tovok, BIBW2992

Tovok,BIBW2992

Tovok|||BIBW 2992

ULXXDDBFHOBEHA-CWDCEQMOSA-N

UNII-41UD74L59M

UNII-V1T5K7RZ0B

USNRYVNRPYXCSP-JUGPPOIOSA-N

V1T5K7RZ0B

X7366

ZINC3976838

ZX-AFC000305

US Patents and Regulatory Information for 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	201292-001	Jul 12, 2013		RX	Yes	No			Y	Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No

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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

Paragraph IV (Patent) Challenges for GILOTRIF

Drugname	Dosage	Strength	RLD	Date
	Tablets	20 mg, 30 mg and 40 mg

Non-Orange Book US Patents for GILOTRIF

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,404,697	Quinazoline derivatives for the treatment of cancer diseases
7,019,012	Quinazoline derivatives and pharmaceutical compositions containing them
9,089,571	Quinazoline derivatives for the treatment of cancer diseases

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International Patents for GILOTRIF

Country	Document Number	Estimated Expiration
Taiwan	I453203
World Intellectual Property Organization (WIPO)	2007054550
Bulgaria	107929

Supplementary Protection Certificates for GILOTRIF

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
370	Luxembourg		PRODUCT NAME: AFATINIB,LES TAUTOMERES,LES STEREOISOMERES ET LES SELS DE CELUI-CI,DES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE CELUI-CI AVEC DES ACIDES OU BASES ORGANIQUES OU INORGANIQUES,DE PREFERENCE UN SEL MALEATE DE CELUI-CI,ET PLUS DE PREFERENCE UN SEL DIMALEATE DE CELUI-CI
00643	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
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