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Last Updated: December 3, 2022

Fluticasone furoate - Generic Drug Details


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What are the generic sources for fluticasone furoate and what is the scope of freedom to operate?

Fluticasone furoate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Glaxosmithkline Cons, and Glaxo Grp Ltd, and is included in four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate has two hundred and thirty-six patent family members in twenty-seven countries.

There are five drug master file entries for fluticasone furoate. Three suppliers are listed for this compound.

Drug Prices for fluticasone furoate

See drug prices for fluticasone furoate

Recent Clinical Trials for fluticasone furoate

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

SponsorPhase
Novartis PharmaceuticalsPhase 3
Emory UniversityPhase 3
SanofiPhase 3

See all fluticasone furoate clinical trials

Pharmacology for fluticasone furoate

US Patents and Regulatory Information for fluticasone furoate

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

EU/EMA Drug Approvals for fluticasone furoate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Avamys fluticasone furoate EMEA/H/C/000770
Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Authorised no no no 2008-01-11
Glaxo Group Ltd. Alisade fluticasone furoate EMEA/H/C/001019
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Withdrawn no no no 2008-10-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for fluticasone furoate

Country Patent Number Title Estimated Expiration
Japan 2005524493 See Plans and Pricing
New Zealand 535873 A fluid dispensing device See Plans and Pricing
Singapore 150524 COUNTER FOR USE WITH A MEDICAMENT DISPENSER See Plans and Pricing
Germany 60330765 See Plans and Pricing
South Korea 100971346 See Plans and Pricing
Portugal 1868731 See Plans and Pricing
United Kingdom 0418278 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fluticasone furoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 LUC00077 Luxembourg See Plans and Pricing 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 08C0014 France See Plans and Pricing PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731 132013902182575 Italy See Plans and Pricing 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
2506844 132018000000341 Italy See Plans and Pricing PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 13C0067 France See Plans and Pricing PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2506844 2018C/022 Belgium See Plans and Pricing PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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