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Last Updated: January 17, 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 four hundred and ninety-four patent family members in fifty-one 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
SRL Mediserch.IncPhase 3
Parexel International JapanPhase 3
York Bioanalytical SolutionPhase 3

See all fluticasone furoate; umeclidinium bromide; vilanterol trifenatate clinical trials

Recent Litigation for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

See all fluticasone furoate; umeclidinium bromide; vilanterol trifenatate litigation

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   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
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 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 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
2506844 122018000060 Germany   Start Trial PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMCELIDINIUM (Z.B. UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
2506844 C20180017 00244 Estonia   Start Trial PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017
1740177 92565 Luxembourg   Start Trial PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
1740177 570 Finland   Start Trial
1425001 C20140013 00103 Estonia   Start Trial PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1740177 2014/057 Ireland   Start Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
McKesson
Merck
Baxter
Colorcon

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