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Last Updated: May 4, 2024

Fluticasone furoate; vilanterol trifenatate - Generic Drug Details

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

Fluticasone furoate; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; vilanterol trifenatate has two hundred and thirteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for fluticasone furoate; vilanterol trifenatate

International Patents:	213
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate; vilanterol trifenatate
DailyMed Link:	fluticasone furoate; vilanterol trifenatate at DailyMed

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

Generic Entry Date for fluticasone furoate; 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; vilanterol trifenatate

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

Sponsor	Phase
York Bioanalytical Solution	Phase 3
Q2 Solutions	Phase 3
SRL Mediserch.Inc	Phase 3

See all fluticasone furoate; vilanterol trifenatate clinical trials

Pharmacology for fluticasone furoate; vilanterol trifenatate

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

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

US Patents and Regulatory Information for fluticasone furoate; 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
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 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

Expired US Patents for fluticasone furoate; vilanterol trifenatate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluticasone furoate; vilanterol trifenatate

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Country	Patent Number	Title	Estimated Expiration
Poland	207531		⤷ Try a Trial
Norway	20082701		⤷ Try a Trial
Cyprus	1114728		⤷ Try a Trial
Lithuania	2400950		⤷ Try a Trial
Spain	2359244		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fluticasone furoate; vilanterol trifenatate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	C20140013 00103	Estonia	⤷ Try a Trial	PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1519731	92269	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1425001	132014902250414	Italy	⤷ Try a Trial	PRODUCT NAME: VILANTEROLO O UN SUO SALE O SOLVATO(RELVAR ELLIPTA); AUTHORISATION NUMBER(S) AND DATE(S): 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
1425001	516	Finland	⤷ Try a Trial
>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.