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Last Updated: November 30, 2022

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 sixteen 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
Q2 Solutions, LLCPhase 3
BI Medical.IncPhase 3

See all umeclidinium bromide clinical trials

Pharmacology for umeclidinium bromide
Drug ClassAnticholinergic
Mechanism of Action Cholinergic 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for umeclidinium bromide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Incruse Ellipta (previously Incruse) umeclidinium bromide EMEA/H/C/002809
Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,
Authorised no no no 2014-04-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for umeclidinium bromide

Country Patent Number Title Estimated Expiration
Cyprus 1113196 See Plans and Pricing
Luxembourg 92565 See Plans and Pricing
Denmark 1730676 See Plans and Pricing
Hong Kong 1089978 MEDICAMENT DISPENSER See Plans and Pricing
European Patent Office 2570128 Antagonistes des récepteurs muscariniques de l'acétylcholine (Muscarinic acetylcholine receptor antagonists) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007012871 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for umeclidinium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 122014000096 Germany See Plans and Pricing PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2506844 18C1022 France See Plans and Pricing 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
1740177 58/2014 Austria See Plans and Pricing PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
1740177 14C0075 France See Plans and Pricing PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1740177 CA 2014 00052 Denmark See Plans and Pricing PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177 1490060-9 Sweden See Plans and Pricing MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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