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ADVAIR HFA Drug Profile

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Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug.

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

The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are twenty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for Tradename: ADVAIR HFA

Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: ADVAIR HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,435,372*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes7,500,444*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,161,724*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ADVAIR HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 20066,251,368*PED<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 2006RE40045<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-001Jun 8, 20065,225,445*PED<disabled>
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Non-Orange Book Patents for Tradename: ADVAIR 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: ADVAIR HFA

Country Document Number Estimated Expiration
Czech Republic9902323<disabled in preview>
Spain2099415<disabled in preview>
Australia5762798<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: ADVAIR HFA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/026United Kingdom<disabled>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
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
269Luxembourg<disabled>PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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