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Last Updated: October 18, 2021

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UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - Generic Drug Details

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What are the generic sources for umeclidinium bromide; vilanterol trifenatate and what is the scope of patent protection?

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

Umeclidinium bromide; vilanterol trifenatate has three hundred and thirty-nine patent family members in forty-seven countries.

There are two drug master file entries for umeclidinium bromide; vilanterol trifenatate. One supplier is listed for this compound.

Summary for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
International Patents:339
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE at DailyMed
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
York Bioanalytical SolutionPhase 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Country Patent Number Estimated Expiration
Poland 1740177 ⤷  Free Forever Trial
Japan 2013512270 ⤷  Free Forever Trial
Russian Federation 2004106555 ⤷  Free Forever Trial
Germany 602004031119 ⤷  Free Forever Trial
Australia 2003250166 ⤷  Free Forever Trial
Costa Rica 20120265 ⤷  Free Forever Trial
Denmark 1730676 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 2018C/022 Belgium ⤷  Free Forever Trial PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1425001 CA 2014 00021 Denmark ⤷  Free Forever Trial PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1740177 14C0075 France ⤷  Free Forever Trial PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1425001 SPC/GB14/034 United Kingdom ⤷  Free Forever 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
1740177 58/2014 Austria ⤷  Free Forever Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
1425001 1490033-6 Sweden ⤷  Free Forever Trial PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
2506844 LUC00077 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
AstraZeneca
Boehringer Ingelheim
McKinsey
Mallinckrodt

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