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Fluticasone furoate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluticasone furoate?

Fluticasone furoate is the generic ingredient in three branded drugs marketed by Glaxosmithkline and Glaxo Grp Ltd, and is included in three NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and forty-seven patent family members in forty countries.

There are twenty-two drug master file entries for fluticasone furoate. Four suppliers are listed for this compound.

Summary for Generic Name: fluticasone furoate

Tradenames:3
Patents:23
Applicants:2
NDAs:3
Drug Master File Entries: see list22
Suppliers / Packagers: see list4
Bulk Api Vendors: see list10
Clinical Trials: see list206
Patent Applications: see list501
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluticasone furoate at DailyMed

Pharmacology for Ingredient: fluticasone furoate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 2014RXYesYes8,113,199► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes8,534,281► SubscribeY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes► Subscribe► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes8,746,242► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluticasone furoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 20145,873,360► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 20145,873,360► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fluticasone furoate

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
6,777,399 Anti-inflammatory androstane derivative compositions► Subscribe
7,798,368Fluid dispensing device► Subscribe
6,787,532 Formulation containing anti-inflammatory androstane derivatives► Subscribe
6,759,398 Anti-inflammatory androstane derivative► Subscribe
7,132,532Compounds useful in the manufacture of an anti-inflammatory androstane derivative► 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 furoate

Country Document Number Estimated Expiration
Australia2001275760► Subscribe
Japan2005523267► Subscribe
Australia2003244506► Subscribe
European Patent Office1472272► Subscribe
Portugal1723052► 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 FUROATE

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
C011/2008Ireland► SubscribeSPC011/2008: 20081105, EXPIRES: 20230110
0343Netherlands► Subscribe300343, 20210803, EXPIRES: 20230110
429Luxembourg► Subscribe91429, EXPIRES: 20230111
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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