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Last Updated: November 18, 2019

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Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

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What are the generic sources for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate and what is the scope of freedom to operate?

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 eighty-nine 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
Parexel International JapanPhase 3
York Bioanalytical SolutionPhase 3
Q2 Solutions, LLCPhase 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   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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Supplementary Protection Certificates for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 C20140032 00132 Estonia   Start Trial PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
1425001 92439 Luxembourg   Start Trial PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
1740177 14C0075 France   Start Trial PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1305329 12/2008 Austria   Start Trial PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111
1425001 14C0028 France   Start Trial PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001 PA2014019,C1425001 Lithuania   Start Trial PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1305329 CA 2008 00022 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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