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Last Updated: April 12, 2024

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 six patent family members in thirty-seven countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for umeclidinium bromide
Generic Entry Date for umeclidinium bromide*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for umeclidinium bromide

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

SponsorPhase
GlaxoSmithKlinePhase 4
SRL Mediserch.IncPhase 3
Parexel International JapanPhase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Eurasian Patent Organization 015033 АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS) ⤷  Try a Trial
Norway 20080474 ⤷  Try a Trial
Canada 2564742 ANTAGONISTES DES RECEPTEURS MUSCARINIQUES DE L'ACETYLCHOLINE (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS) ⤷  Try a Trial
Japan 5398871 ⤷  Try a Trial
Japan 2009502287 ⤷  Try a Trial
Japan 2007534769 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for umeclidinium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 122018000060 Germany ⤷  Try a Trial PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM (EINSCHLIESSLICH UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (EINSCHLIESSLICH VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1740177 208 50012-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
1740177 C01740177/02 Switzerland ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
2506844 300942 Netherlands ⤷  Try a Trial PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117
1740177 58/2014 Austria ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
1740177 C01740177/03 Switzerland ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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