Umeclidinium bromide - Generic Drug Details

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 seven 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:	107
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

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

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			Y	Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes					Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes					Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes

Expired US Patents for umeclidinium bromide

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

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

International Patents for umeclidinium bromide

Country	Patent Number	Title	Estimated Expiration
Australia	2005237576	Muscarinic Acetylcholine Receptor Antagonists
Brazil	PI0510170	antagonistas do receptor muscarìnico de acetilcolina
Mexico	PA06012405	ANTAGONISTAS DEL RECEPTOR ACETILCOLINA MUSCARINICO. (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS.)
Cyprus	1118082
Japan	4960868
Spain	2392848
Japan	2009502287

Supplementary Protection Certificates for umeclidinium bromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	PA2014038	Lithuania		PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177	1490060-9	Sweden		MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1740177	570	Finland
1740177	CA 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177	122014000096	Germany		PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428