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Last Updated: April 24, 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 twelve 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
BI Medical.IncPhase 3
York Bioanalytical SolutionPhase 3
Q2 SolutionsPhase 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 ⤷  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 204275-001 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 204275-002 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 204275-003 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
>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
Portugal 1907037 ⤷  Try a Trial
Israel 160595 ⤷  Try a Trial
Spain 2734302 ⤷  Try a Trial
Brazil 0306799 DISPENSADOR DE MEDICAMENTO ⤷  Try a Trial
Mexico PA04007129 DISTRIBUIDOR DE MEDICAMENTO. (MEDICAMENT DISPENSER.) ⤷  Try a Trial
South Africa 200405701 MEDICAMENT DISPENSER ⤷  Try a Trial
>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
1519731 132013902182575 Italy ⤷  Try a Trial PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1425001 174 50004-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1425001 C300664 Netherlands ⤷  Try a Trial PRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001 PA2014019,C1425001 Lithuania ⤷  Try a Trial PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
2506844 LUC00077 Luxembourg ⤷  Try a Trial PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1305329 SPC/GB08/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
>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.