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Last Updated: July 13, 2020

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FLOVENT HFA Drug 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 four patents protecting this drug.

This drug has eighty-eight patent family members in nineteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Flovent Hfa

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

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Drug patent expirations by year for FLOVENT HFA
Drug Prices for FLOVENT HFA

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Drug Sales Revenue Trends for FLOVENT HFA

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Recent Clinical Trials for FLOVENT HFA

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SponsorPhase
Teva Pharmaceuticals USAPhase 3
Actavis Inc.Phase 3
University of PittsburghPhase 1

See all FLOVENT HFA clinical trials

Pharmacology for FLOVENT HFA
Paragraph IV (Patent) Challenges for FLOVENT HFA
Tradename Dosage Ingredient NDA Submissiondate
FLOVENT HFA AEROSOL, METERED;INHALATION fluticasone propionate 021433 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   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start 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 021433-002 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
>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
2506844 132018000000341 Italy   Start 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 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329 SPC/GB08/026 United Kingdom   Start Trial PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
2506844 1890025-8 Sweden   Start Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731 132013902182575 Italy   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Colorcon
McKinsey
Merck
Harvard Business School

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