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Fluticasone propionate; salmeterol xinafoate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluticasone propionate; salmeterol xinafoate?

Fluticasone propionate; salmeterol xinafoate is the generic ingredient in five branded drugs marketed by Glaxo Grp Ltd and Teva Pharm, and is included in three NDAs. There are thirty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has four hundred and twenty-five patent family members in fifty-seven countries.

There are twenty-two drug master file entries for fluticasone propionate; salmeterol xinafoate. Nine suppliers are listed for this compound.

Summary for Generic Name: fluticasone propionate; salmeterol xinafoate

Tradenames:5
Patents:31
Applicants:2
NDAs:3
Drug Master File Entries: see list22
Suppliers / Packagers: see list9
Clinical Trials: see list207
Drug Prices:see low prices
DailyMed Link:fluticasone propionate; salmeterol xinafoate at DailyMed

Pharmacology for Ingredient: fluticasone propionate; salmeterol xinafoate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 2006RXYesYes7,832,351*PED► SubscribeY► Subscribe
Teva Pharm
AIRDUO RESPICLICK
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION208799-003Jan 27, 2017RXYesYes8,651,103► SubscribeY ► Subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 2006RXYesYes7,107,986*PED► SubscribeY► Subscribe
Teva Pharm
AIRDUO RESPICLICK
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION208799-003Jan 27, 2017RXYesYes9,066,957► SubscribeY ► Subscribe
Teva Pharm
AIRDUO RESPICLICK
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION208799-001Jan 27, 2017RXYesNo9,216,260► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluticasone propionate; salmeterol xinafoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR DISKUS 500/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-003Aug 24, 20007,389,775*PED► Subscribe
Glaxo Grp Ltd
ADVAIR DISKUS 100/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-001Aug 24, 20004,335,121*PED► Subscribe
Glaxo Grp Ltd
ADVAIR DISKUS 500/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-003Aug 24, 20004,992,474*PED► Subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 20066,524,555► Subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 20065,674,472*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fluticasone propionate; salmeterol xinafoate

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
7,389,775Inhalation device► Subscribe
9,533,111Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,378,519 Inhalation device► Subscribe
7,101,534Suspension aerosol formulations► Subscribe
5,860,419 Inhalation device► 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 Ingredient: fluticasone propionate; salmeterol xinafoate

Country Document Number Estimated Expiration
European Patent Office2514467► Subscribe
European Patent Office1330280► Subscribe
African Regional IP Organization (ARIPO)9901587► Subscribe
Denmark1667627► Subscribe
Spain2216800► 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: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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