Fluticasone furoate - Generic Drug Details

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What are the generic sources for fluticasone furoate and what is the scope of freedom to operate?

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 three hundred and ninety-five 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:	395
US Patents:	27
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	29
Suppliers / Packagers:	2
Bulk Api Vendors:	17
Clinical Trials:	136
Patent Applications:	664
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

(6\|A,11\|A,16\|A,17\|A)-6,9-Difluoro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioic Acid S-(Fluoromethyl) Ester
(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
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
GW 685698
GW 685698X
GW-685698
GW-685698X
GW6
gw685698
GW685698X
JS86977WNV
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
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
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
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	Start Trial	Start Trial				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
Slovenia	1775305	Start Trial
Singapore	150525	Start Trial
United Kingdom	0525237	Start Trial
Norway	338541	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	326	Finland	Start Trial
1519731	13C0067	France	Start Trial	PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1305329	C01305329/01	Switzerland	Start Trial	PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
1305329	CA 2008 00022	Denmark	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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