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Last Updated: February 28, 2021

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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-seven 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:177
US Patents:15
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 44
Clinical Trials: 19
Patent Applications: 148
DailyMed Link:umeclidinium bromide at DailyMed
Recent Clinical Trials for umeclidinium bromide

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

GlaxoSmithKlinePhase 4
Parexel International JapanPhase 3
York Bioanalytical SolutionPhase 3

See all umeclidinium bromide clinical trials

Pharmacology for umeclidinium bromide
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

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
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
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 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 2014/057 Ireland   Start Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177 14C0075 France   Start Trial PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1740177 58/2014 Austria   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
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