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 eight patent family members in thirty-seven countries.

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

Summary for UMECLIDINIUM BROMIDE

International Patents:	108
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	20
Patent Applications:	619
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UMECLIDINIUM BROMIDE
DailyMed Link:	UMECLIDINIUM BROMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for UMECLIDINIUM BROMIDE

Generic Entry Date for UMECLIDINIUM BROMIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
GlaxoSmithKline	Phase 4
Q2 Solutions, LLC	Phase 3
BI Medical.Inc	Phase 3

See all UMECLIDINIUM BROMIDE clinical trials

Pharmacology for UMECLIDINIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for UMECLIDINIUM BROMIDE

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for UMECLIDINIUM BROMIDE

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Glossary

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

Expired US Patents for UMECLIDINIUM BROMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for UMECLIDINIUM BROMIDE

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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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	144753	MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS	⤷ Sign Up
Japan	2012254315	MEDICATION DISPENSER	⤷ Sign Up
Japan	5608197		⤷ Sign Up
Eurasian Patent Organization	015033	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)	⤷ Sign Up
South Korea	101037026		⤷ Sign Up
South Africa	200608565	MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS	⤷ Sign Up
Poland	1907037		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	PA2014038,C1740177	Lithuania	⤷ Sign Up	PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
2506844	122018000060	Germany	⤷ Sign Up	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	300694	Netherlands	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1740177	58/2014	Austria	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
1740177	C300694	Netherlands	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	1490060-9	Sweden	⤷ Sign Up	MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844	23/2018	Austria	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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