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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-two 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
Drug Prices: :see details
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, 2006RXYes7,107,986*PED► subscribeY► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,170,717*PED► subscribeY► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes7,832,351*PED► subscribeY► subscribe
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Expired Patents for Tradename: ADVAIR HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 20066,251,368*PED► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-001Jun 8, 2006RE40045► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 20065,674,472*PED► subscribe
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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► 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: ADVAIR HFA

Country Document Number Estimated Expiration
Austria260641► subscribe
Brazil9714091► subscribe
Australia709052► 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: ADVAIR HFA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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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