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Last Updated: March 29, 2024

Umeclidinium bromide; vilanterol trifenatate - Generic Drug Details


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

Umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide; vilanterol trifenatate has three hundred and fifty-two patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for umeclidinium bromide; vilanterol trifenatate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for umeclidinium bromide; vilanterol trifenatate
Generic Entry Date for umeclidinium bromide; vilanterol trifenatate*:
Constraining patent/regulatory exclusivity:
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 umeclidinium bromide; vilanterol trifenatate

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

SponsorPhase
SRL Mediserch.IncPhase 3
Parexel International JapanPhase 3
GlaxoSmithKlinePhase 3

See all umeclidinium bromide; vilanterol trifenatate clinical trials

Pharmacology for umeclidinium bromide; vilanterol trifenatate

US Patents and Regulatory Information for 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 ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  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 umeclidinium bromide; vilanterol trifenatate

International Patents for umeclidinium bromide; vilanterol trifenatate

Country Patent Number Title Estimated Expiration
Denmark 1651296 ⤷  Try a Trial
Brazil 112018069147 composto da fórmula iii, composição farmacêutica, método de inibição da função de fimh e método de tratamento de uma doença mediada por fimh ⤷  Try a Trial
Canada 2493078 ⤷  Try a Trial
Hungary E031304 ⤷  Try a Trial
Canada 2533333 DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER) ⤷  Try a Trial
Poland 2570128 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for umeclidinium bromide; vilanterol trifenatate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 C20140013 00103 Estonia ⤷  Try a Trial PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
2506844 300942 Netherlands ⤷  Try a Trial PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117
1425001 C01425001/01 Switzerland ⤷  Try a Trial PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1740177 122014000096 Germany ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1425001 C300664 Netherlands ⤷  Try a Trial PRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001 SPC/GB14/034 United Kingdom ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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