Fluticasone furoate - Generic Drug Details

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What are the generic sources for fluticasone furoate and what is the scope of patent protection?

Fluticasone furoate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Glaxosmithkline Cons, and Glaxo Grp Ltd, and is included in four NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate has four hundred and two patent family members in forty-one countries.

There are twenty-nine drug master file entries for fluticasone furoate. Two suppliers are listed for this compound.

Summary for fluticasone furoate

International Patents:	402
US Patents:	27
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	29
Suppliers / Packagers:	2
Bulk Api Vendors:	19
Clinical Trials:	136
Patent Applications:	666
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluticasone furoate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate
DailyMed Link:	fluticasone furoate at DailyMed

See drug prices for fluticasone furoate

Recent Clinical Trials for fluticasone furoate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bispebjerg Hospital	Phase 2
Parexel	Phase 4
University of Saskatchewan	Phase 4

See all fluticasone furoate clinical trials

Recent Litigation for fluticasone furoate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

See all fluticasone furoate litigation

Pharmacology for fluticasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for fluticasone furoate

(6alpha,11alpha,14beta,16alpha,17alpha)-6,9-Difluoro-17-{[(Fluoromethyl)sulfanyl]carbonyl}-11-Hydroxy-16-Methyl-3-Oxoandrosta-1,4-Dien-17-Yl Furan-2-Carboxylate
(6alpha,11beta,16alpha,17alpha)-6,9-Difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate
397864-44-7
6alpha,9-Difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11beta-hydroxy-16alpha-methyl-3-oxoandrosta-1,4-dien-17alpha-yl furan-2-carboxylate
6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl 2-furoate
779352-12-4
911210-90-7
Alisade
Allermist
Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-17-((2- furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) ester, (6alpha,11beta,16alpha,17alpha)-
Arnuity Ellipta
Avamys
Avamys pound>> Veramyst pound>> Allermist
BCP18136
BDBM50354851
CHEBI:74899
CHEMBL1676
D06315
DB08906
DTXSID60228586
Flonase Sensimist
Flonase Sensimist Allergy Relief
fluticason furoate
Fluticasone fuorate
Fluticasone furancarboxylate
Fluticasone furoate (JAN/USAN/INN)
Fluticasone furoate [USAN:INN]
fluticasonum furoas
FT-0668768
Furamist
furoate de fluticasone
furoato de fluticasona
GSK 685 698
GSK 685698
GSK-685968
GSK685968
GW 685698
GW 685698X
GW-685698
GW-685698X
GW6
gw685698
GW685698X
JS86977WNV
Q2166700
s6487
SCHEMBL140504
UNII-JS86977WNV
Veramyst
Veramyst (TN)
ZINC3992105

US Patents and Regulatory Information for fluticasone furoate

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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
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
>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 fluticasone furoate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	Start Trial	Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluticasone furoate

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Country	Patent Number	Estimated Expiration
Portugal	1960021	Start Trial
Australia	2003207016	Start Trial
Germany	602004031119	Start Trial
Australia	2003205850	Start Trial
European Patent Office	1651296	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for fluticasone furoate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	C 2008 007	Romania	Start Trial	PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111
2506844	2018C/022	Belgium	Start Trial	PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	132018000000341	Italy	Start Trial	PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1305329	300343	Netherlands	Start Trial	300343, 20210803, EXPIRES: 20230110
1519731	92269	Luxembourg	Start Trial	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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