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Last Updated: March 29, 2024

FLOVENT HFA Drug Patent Profile


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When do Flovent Hfa patents expire, and when can generic versions of Flovent Hfa launch?

Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-nine patent family members in seventeen countries.

The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Flovent Hfa

A generic version of FLOVENT HFA was approved as fluticasone propionate by FOUGERA PHARMS on May 14th, 2004.

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Paragraph IV (Patent) Challenges for FLOVENT HFA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLOVENT HFA Inhalation Aerosol fluticasone propionate 0.22 mcg/inh 021433 1 2021-10-29
FLOVENT HFA Inhalation Aerosol fluticasone propionate 0.11 mcg/inh 021433 1 2016-12-23

US Patents and Regulatory Information for FLOVENT HFA

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 FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 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 FLOVENT HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FLOVENT HFA

See the table below for patents covering FLOVENT HFA around the world.

Country Patent Number Title Estimated Expiration
Spain 2175737 ⤷  Try a Trial
Australia 3085292 ⤷  Try a Trial
United Kingdom 9721875 ⤷  Try a Trial
Russian Federation 2179037 CYLINDER FOR DELIVERY OF PHARMACEUTICAL COMPOSITION, DOSING INHALATOR ⤷  Try a Trial
Spain 2159678 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9856445 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLOVENT HFA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
1305329 08C0014 France ⤷  Try a Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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