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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 three 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:	403
US Patents:	27
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	29
Suppliers / Packagers:	2
Bulk Api Vendors:	25
Clinical Trials:	139
Patent Applications:	1,538
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
Chiesi Farmaceutici S.p.A.	Phase 4
Dr. Grace Parraga	Phase 3
Shiraz University of Medical Sciences	N/A

See all fluticasone furoate clinical trials

Pharmacology for fluticasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for fluticasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes			Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes			Y	Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes			Y	Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes			Y

Expired US Patents for fluticasone furoate

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

International Patents for fluticasone furoate

Country	Patent Number	Estimated Expiration
Japan	4436041
Poland	1786498
World Intellectual Property Organization (WIPO)	2005044354
South Africa	200300929
Hungary	E045371

Supplementary Protection Certificates for fluticasone furoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1305329	326	Finland
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
1305329	300343	Netherlands		300343, 20210803, EXPIRES: 20230110