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Last Updated: March 19, 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 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 ⤷  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
South Africa 200405701 MEDICAMENT DISPENSER ⤷  Try a Trial
Hungary E041427 ⤷  Try a Trial
Peru 20130042 COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2 ⤷  Try a Trial
Colombia 5560552 DERIVADOS DE FENETANOLAMINA PARA EL TRATAMIENTO DE ENFERMEDADES RESPIRATORIAS ⤷  Try a Trial
Portugal 2570128 ⤷  Try a Trial
Cyprus 1111614 ⤷  Try a Trial
Australia 2005274296 Medicament dispenser ⤷  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
2506844 C201830030 Spain ⤷  Try a Trial PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115
1425001 516 Finland ⤷  Try a Trial
2506844 132018000000341 Italy ⤷  Try a 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
1425001 CA 2014 00021 Denmark ⤷  Try a Trial PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1740177 C20140032 00132 Estonia ⤷  Try a Trial PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
1740177 C01740177/02 Switzerland ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
1740177 14C0075 France ⤷  Try a Trial PRODUCT NAME: BROMURE D'UMECLIDINIUM; 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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