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ADVAIR DISKUS 100/50 Drug Profile

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Advair Diskus 100/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from nine suppliers. There is one patent protecting this drug.

This drug has seventy-eight patent family members in forty-one countries.

The generic ingredient in ADVAIR DISKUS 100/50 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 DISKUS 100/50

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list9
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: ADVAIR DISKUS 100/50

Clinical Trials for: ADVAIR DISKUS 100/50

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
ADVAIR DISKUS 100/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-001Aug 24, 2000RXYes5,873,360*PEDAug 23, 2016Y
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Expired Patents for Tradename: ADVAIR DISKUS 100/50

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR DISKUS 100/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-001Aug 24, 20006,378,519*PED<disabled>
Glaxo Grp Ltd
ADVAIR DISKUS 100/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-001Aug 24, 20006,536,427*PED<disabled>
Glaxo Grp Ltd
ADVAIR DISKUS 100/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-001Aug 24, 2000RE40045<disabled>
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Non-Orange Book Patents for Tradename: ADVAIR DISKUS 100/50

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
2,006,107,948<disabled in preview>
6,032,666 Inhalation device<disabled in preview>
5,860,419 Inhalation device<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 DISKUS 100/50

Country Document Number Estimated Expiration
Australia645056<disabled in preview>
Singapore169094<disabled in preview>
New Zealand260140<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 DISKUS 100/50

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
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
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