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Last Updated: October 7, 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 freedom to operate?

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 fourteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Generic Entry Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Q2 Solutions, LLCPhase 3
BI Medical.IncPhase 3
York Bioanalytical SolutionPhase 3

See all FLUTICASONE FUROATE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

US Patents and Regulatory Information for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-003 May 12, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-003 May 12, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

International Patents for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Country Patent Number Title Estimated Expiration
Poland 371862 ⤷  Sign Up
Cyprus 1109422 ⤷  Sign Up
Portugal 2400950 ⤷  Sign Up
South Korea 101425803 ⤷  Sign Up
Russian Federation 2004106555 ⤷  Sign Up
Brazil PI0411773 dispensador de medicamento para conter diversos porta-medicamentos de forma alongada, e, uso do mesmo ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 174 50004-2014 Slovakia ⤷  Sign Up PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1425001 CR 2014 00021 Denmark ⤷  Sign Up PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
1425001 14C0028 France ⤷  Sign Up 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
1305329 08C0014 France ⤷  Sign Up PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1425001 SPC/GB14/034 United Kingdom ⤷  Sign Up PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
2506844 SPC/GB18/020 United Kingdom ⤷  Sign Up PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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