You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Fluticasone furoate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

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. Three 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
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 ⤷  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 ⤷  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
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
>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
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
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 205625-003 May 17, 2018 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 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 2018C/022 Belgium ⤷  Try a Trial 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
1519731 92269 Luxembourg ⤷  Try a Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.