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FLOVENT HFA Drug Profile

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Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from four suppliers. 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-one drug master file entries for this compound. Sixty-three 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

Pharmacology for Tradename: FLOVENT HFA

Clinical Trials for: FLOVENT HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYes6,435,372*PED<disabled>Y<disabled>
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYes7,500,444*PED<disabled>Y<disabled>
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 2004RXYes6,161,724*PED<disabled>Y<disabled>
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Expired Patents for Tradename: FLOVENT HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 20046,251,368*PED<disabled>
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-001May 14, 20045,658,549*PED<disabled>
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-003May 14, 20046,596,260*PED<disabled>
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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<disabled in preview>
7,105,152Suspension aerosol formulations<disabled in preview>
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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
United Kingdom9626960<disabled in preview>
Czech Republic291955<disabled in preview>
African Regional IP Organization (ARIPO)9901587<disabled in preview>
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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<disabled>PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
269Luxembourg<disabled>PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0067France<disabled>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
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