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Last Updated: August 2, 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 freedom to operate?

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
Recent Clinical Trials for UMECLIDINIUM BROMIDE

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

SponsorPhase
GlaxoSmithKlinePhase 4
BI Medical.IncPhase 3
SRL Mediserch.IncPhase 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
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 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 ⤷  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
>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 CA 2014 00052 Denmark ⤷  Free Forever Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177 300694 Netherlands ⤷  Free Forever Trial PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1740177 CR 2014 00052 Denmark ⤷  Free Forever Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Medtronic
Boehringer Ingelheim
Moodys
Baxter

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