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Last Updated: April 25, 2024

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - Generic Drug Details

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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 twelve patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

International Patents:	212
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

Generic Entry Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
York Bioanalytical Solution	Phase 3
Q2 Solutions	Phase 3
SRL Mediserch.Inc	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

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

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

International Patents for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	0418278		⤷ Try a Trial
United Kingdom	0126997		⤷ Try a Trial
Portugal	1960021		⤷ Try a Trial
Canada	2616193	DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER)	⤷ Try a Trial
Brazil	PI0216127	composto derivado de fenetanolamina, formulação farmacêutica, combinação farmacêutica, uso de um composto, processo para preparar um composto, e, intermediário	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	2018C/022	Belgium	⤷ Try a 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
1425001	516	Finland	⤷ Try a Trial
1425001	174 50004-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1425001	C01425001/02	Switzerland	⤷ Try a Trial	PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1425001	CR 2014 00021	Denmark	⤷ Try a Trial	PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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

Recent Clinical Trials for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Pharmacology for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Make Better Decisions: Try a trial or see plans & pricing

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