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Last Updated: March 19, 2024

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, Haleon Us Holdings, and Glaxo Grp Ltd, and is included in four NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for fluticasone furoate

See drug prices for fluticasone furoate

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fluticasone furoate
Generic Entry Dates for fluticasone furoate*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
Dosage:
POWDER;INHALATION
Generic Entry Dates for fluticasone furoate*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;NASAL

*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

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

SponsorPhase
Novartis PharmaceuticalsPhase 3
Assaf-Harofeh Medical CenterPhase 4
Emory UniversityPhase 3

See all fluticasone furoate clinical trials

Pharmacology for fluticasone furoate
Paragraph IV (Patent) Challenges for FLUTICASONE FUROATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLONASE SENSIMIST ALLERGY RELIEF Nasal Spray fluticasone furoate 27.5 mcg 022051 1 2011-07-15

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 ⤷  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 Y 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Supplementary Protection Certificates for fluticasone furoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 18C1022 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844 132018000000341 Italy ⤷  Try a Trial 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 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
2506844 SPC/GB18/020 United Kingdom ⤷  Try a Trial 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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