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FLOVENT HFA Drug Profile

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Which patents cover Flovent Hfa, and what substitute generic drugs are available?

Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fifteen patents protecting this drug.

This drug has eighty-one patent family members in thirty-four countries.

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

Summary for Tradename: FLOVENT HFA

Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list44
Clinical Trials: see list90
Patent Applications: see list9,829
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FLOVENT HFA at DailyMed

Pharmacology for Tradename: FLOVENT HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYesYes7,107,986*PED► SubscribeY► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYesYes6,170,717*PED► SubscribeY► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYesYes7,832,351*PED► SubscribeY► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-002May 14, 2004RXYesYes7,350,676*PED► SubscribeY► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYesYes6,315,173*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: FLOVENT HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-003May 14, 20046,251,368*PED► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-003May 14, 20045,674,472*PED► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-002May 14, 20046,596,260*PED► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 20045,658,549*PED► Subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-002May 14, 20045,658,549*PED► Subscribe
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Non-Orange Book Patents for Tradename: FLOVENT HFA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,101,534Suspension aerosol formulations► Subscribe
7,105,152Suspension aerosol formulations► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FLOVENT HFA

Country Document Number Estimated Expiration
Yugoslavia49329► Subscribe
Eurasian Patent Organization001164► Subscribe
Germany69233319► Subscribe
Czech Republic9902323► Subscribe
China1241979► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FLOVENT HFA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0014France► SubscribePRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
C0067France► SubscribePRODUCT 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
C/GB08/026United Kingdom► SubscribePRODUCT 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
269Luxembourg► SubscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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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 verifification 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.

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