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Last Updated: November 20, 2024

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - Generic Drug Details

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What are the generic drug sources for umeclidinium bromide; vilanterol trifenatate and what is the scope of patent protection?

Umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide; vilanterol trifenatate has three hundred and twenty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

International Patents:	329
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
DailyMed Link:	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE at DailyMed

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

Generic Entry Date for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE^: ⤷ 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; VILANTEROL TRIFENATATE

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

Sponsor	Phase
Q2 Solutions	Phase 3
SRL Mediserch.Inc	Phase 3
Parexel International Japan	Phase 3

See all UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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; VILANTEROL TRIFENATATE

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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				⤷ 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
>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; VILANTEROL TRIFENATATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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Country	Patent Number	Title	Estimated Expiration
Australia	2003254590		⤷ Sign Up
China	107412229	毒蕈碱受体拮抗剂和β‑2肾上腺素受体激动剂的组合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)	⤷ Sign Up
Norway	342119		⤷ Sign Up
Hong Kong	1066479		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005104745		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	208 50012-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
1740177	C 2014 041	Romania	⤷ Sign Up	PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428
1425001	2014C/026	Belgium	⤷ Sign Up	PRODUCT NAME: VILANTEROL TRIFENATATE; AUTHORISATION NUMBER AND DATE: EU/1/13/886/001 20131114
2506844	300942	Netherlands	⤷ Sign Up	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
2506844	C201830030	Spain	⤷ Sign Up	PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.