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Last Updated: July 15, 2020

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

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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 nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has five hundred and three patent family members in fifty-two countries.

There are twenty-nine drug master file entries for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. One supplier is listed for this compound.

Recent Clinical Trials for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

SponsorPhase
BI Medical.IncPhase 3
SRL Mediserch.IncPhase 3
Parexel International JapanPhase 3

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

Pharmacology for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1305329 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1425001 1490033-6 Sweden   Start Trial PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1425001 SPC/GB14/034 United Kingdom   Start Trial 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 132018000000341 Italy   Start Trial 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
1305329 122008000029 Germany   Start Trial PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
McKesson
Mallinckrodt
Medtronic
Colorcon

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