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Last Updated: May 26, 2022

FLOVENT HFA Drug Patent Profile


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Which patents cover Flovent Hfa, 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 are two patents 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. Sixty-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 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 FLOVENT HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FLOVENT HFA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
2506844 18C1022 France See Plans and Pricing 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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