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Last Updated: May 4, 2024

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

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

Fluticasone furoate; 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.

Fluticasone furoate; 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 fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

International Patents:	329
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
DailyMed Link:	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Generic Entry Date for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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

Sponsor	Phase
Parexel International Japan	Phase 3
GlaxoSmithKline	Phase 3
Q2 Solutions, LLC	Phase 3

See all fluticasone furoate; umeclidinium bromide; vilanterol trifenatate clinical trials

Pharmacology for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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 fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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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	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ 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

Expired US Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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Country	Patent Number	Title	Estimated Expiration
Cyprus	2014043		⤷ Try a Trial
Canada	2533333	DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER)	⤷ Try a Trial
South Korea	20110010841	MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS	⤷ Try a Trial
China	1671435		⤷ Try a Trial
European Patent Office	3432892	ANTAGONISTES DÉRIVÉS DU MANNOSE DE FIMH UTILES POUR LE TRAITEMENT D'UNE MALADIE (MANNOSE-DERIVED ANTAGONISTS OF FIMH USEFUL FOR TREATING DISEASE)	⤷ Try a Trial
European Patent Office	2266650	Distributeur de médicaments (Medicament dispenser)	⤷ Try a Trial
Australia	2014204459	COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	2014C/026	Belgium	⤷ Try a Trial	PRODUCT NAME: VILANTEROL TRIFENATATE; AUTHORISATION NUMBER AND DATE: EU/1/13/886/001 20131114
1740177	1490060-9	Sweden	⤷ Try a Trial	MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
1519731	92269	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1740177	C01740177/02	Switzerland	⤷ Try a Trial	PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
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
1425001	14C0028	France	⤷ Try a Trial	PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	122014000051	Germany	⤷ Try a Trial	PRODUCT NAME: VILANTEROL ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
>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.