FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - Generic Drug Details

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

Fluticasone furoate; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; vilanterol trifenatate has two hundred and thirteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

International Patents:	213
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
DailyMed Link:	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Dosage:

POWDER;INHALATION

^*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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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

Sponsor	Phase
SRL Mediserch.Inc	Phase 3
Parexel International Japan	Phase 3
Q2 Solutions, LLC	Phase 3

See all FLUTICASONE FUROATE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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	204275-003	May 12, 2023		RX	Yes	No					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes					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; VILANTEROL TRIFENATATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015

International Patents for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Country	Patent Number	Title	Estimated Expiration
Denmark	1651296
Cyprus	1114728
Brazil	PI0619732	distribuidor para uso em um dispositivo de dispensação de medicamento, subconjunto de distribuidor e bocal, e, dispositivo de dispensação de medicamento
China	1622838
Portugal	1467789
Malaysia	129422	MEDICINAL COMPOUNDS

Supplementary Protection Certificates for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1425001	132014902250414	Italy		PRODUCT NAME: VILANTEROLO O UN SUO SALE O SOLVATO(RELVAR ELLIPTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/886/001-006, 20131113
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1425001	92439	Luxembourg		PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
1425001	14C0028	France		PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113