FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - Generic Drug Details

What are the generic drug sources for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate and what is the scope of patent protection?

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has three hundred and twenty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

International Patents:	329
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
DailyMed Link:	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE at DailyMed

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

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

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

See all FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

US Patents and Regulatory Information for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y

Expired US Patents for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017

International Patents for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Country	Patent Number	Title	Estimated Expiration
Israel	219893	שילובים של אנטגוניסט לקולטן מוסקריני ואגוניסט לקולטן בתא-2-אדרנו (Combinations of a muscarinic receptor antagonist and a beta-2 adrenorecptor agonist)
Canada	2755954	DERIVES DE QUINUCLIDINE QUATERNAIRE ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE (QUATERNARY QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC RECEPTOR ANTAGONISTS)
Taiwan	I363759
European Patent Office	1467790
South Korea	20080080636	MANIFOLD FOR USE IN MEDICAMENT DISPENSER

Supplementary Protection Certificates for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	C201830030	Spain		PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115
1740177	C20140032 00132	Estonia		PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
1519731	13C0067	France		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
1425001	C01425001/01	Switzerland		PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
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