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 fourteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

International Patents:	214
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Q2 Solutions	Phase 3
SRL Mediserch.Inc	Phase 3
Parexel International Japan	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

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	204275-002	Apr 30, 2015	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Sign Up	⤷ Sign Up
>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
China	100528256		⤷ Sign Up
Taiwan	I299661		⤷ Sign Up
Australia	2003254590		⤷ Sign Up
Brazil	PI0614568	dispensador de medicamento	⤷ Sign Up
Poland	371862		⤷ Sign Up
European Patent Office	1907037	DISTRIBUTEUR DE MÉDICAMENTS (MEDICAMENT DISPENSER)	⤷ Sign Up
>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
1425001	1490033-6	Sweden	⤷ Sign Up	PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1425001	SPC/GB14/034	United Kingdom	⤷ Sign Up	PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
2506844	18C1022	France	⤷ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844	132018000000341	Italy	⤷ Sign Up	PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1425001	2014/024	Ireland	⤷ Sign Up	PRODUCT NAME: VILANTEROL OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	516	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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