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Last Updated: May 31, 2020

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Umeclidinium bromide - Generic Drug Details

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

Umeclidinium bromide is the generic ingredient in two branded drugs marketed by Glaxo Grp England and Glaxosmithkline, and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide has one hundred and seventy-six patent family members in thirty-nine countries.

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

Summary for umeclidinium bromide
International Patents:176
US Patents:15
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 36
Clinical Trials: 19
Patent Applications: 146
DailyMed Link:umeclidinium bromide at DailyMed
Recent Clinical Trials for umeclidinium bromide

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

SponsorPhase
GlaxoSmithKlinePhase 4
Q2 Solutions, LLCPhase 3
BI Medical.IncPhase 3

See all umeclidinium bromide clinical trials

Pharmacology for umeclidinium bromide
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Synonyms for umeclidinium bromide
1-(2-(Benzyloxy)ethyl)-4-(hydroxydiphenylmethyl)-1-azoniabicyclo(2.2.2)octane bromide
1-(2-(benzyloxy)ethyl)-4-(hydroxydiphenylmethyl)quinuclidin-1-ium bromide
1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azabicyclo[2.2.2]octan-1-ium bromide
1-[2-(Benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-quinuclidinium Bromide
1-[2-(benzyloxy)ethyl]-4-[hydroxy(diphenyl)methyl]-1-azoniabicyclo[2.2.2]octane bromide
1-Azoniabicyclo(2.2.2)octane, 4-(hydroxydiphenylmethyl)-1-(2-(phenylmethoxy)ethyl)-, bromide (1:1)
1-Azoniabicyclo[2.2.2]octane, 4-(hydroxydiphenylmethyl)-1-[2-(phenylmethoxy)ethyl]-, bromide (1:1)
4-[Hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl)oxy]ethyl}-1-azoniabicyclo[2.2.2]octane Bromide
7AN603V4JV
869113-09-7
AK174796
AKOS025404842
AS-57320
BCP11148
bromure d'umeclidinium
bromuro de umeclidinio
CHEBI:79040
CHEMBL523299
CS-0874
D10181
diphenyl-[1-(2-phenylmethoxyethyl)-1-azoniabicyclo[2.2.2]octan-4-yl]methanol;bromide
DTXSID50235966
EX-A1683
GSK-573719
GSK-573719 pound>> GSK573719 pound>> GSK 573719 pound>>GSK573719A;GSK-573719A;GSK 573719A
GSK-573719A
GSK573719A
HY-12100
Incruse Ellipta
Incruse ellipta (TN)
KS-00001CW3
PEJHHXHHNGORMP-UHFFFAOYSA-M
Q15624035
SB16738
SCHEMBL109931
SY226333
umeclidinii bromidum
Umeclidinium (bromide)
Umeclidinium brom
Umeclidinium bromide (JAN/USAN)
Umeclidinium bromide [USAN:INN]
Umeclidinium bromide(GSK573719A)
umeclidinium-bromide
Umeclidinium(bromide)
UNII-7AN603V4JV
VA12030

US Patents and Regulatory Information for umeclidinium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 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 umeclidinium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 14C0075 France   Start Trial PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
2506844 23/2018 Austria   Start Trial PRODUCT NAME: EIN PHARMAZEUTISCHES KOMBINATIONSPRODUKT, UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM, VILANTEROL ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON UND FLUTICASONFUROAT; REGISTRATION NO/DATE: EU/1/17/1236 (MITTEILUNG) 20171117
1740177 C01740177/02 Switzerland   Start Trial PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
1740177 1490060-9 Sweden   Start Trial MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844 1890025-8 Sweden   Start Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1740177 2014/057 Ireland   Start Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2506844 18C1022 France   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/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:

Baxter
Johnson and Johnson
McKesson
Harvard Business School
Medtronic
Dow

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