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Generated: September 21, 2017

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Fluticasone furoate - Generic Drug Details

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What are the generic drug sources for fluticasone furoate and what is the scope of fluticasone furoate freedom to operate?

Fluticasone furoate
is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Glaxosmithkline Cons, 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.

Fluticasone furoate has three hundred and fifty-seven patent family members in forty-one countries.

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

Summary for Generic Name: fluticasone furoate

Tradenames:3
Patents:22
Applicants:3
NDAs:3
Drug Master File Entries: see list24
Suppliers / Packagers: see list4
Bulk Api Vendors: see list10
Clinical Trials: see list588
Patent Applications: see list639
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Cons
FLONASE SENSIMIST ALLERGY RELIEF
fluticasone furoate
SPRAY, METERED;NASAL022051-002Aug 2, 2016OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes► Subscribe► 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;INHALATION205625-001Aug 20, 2014► Subscribe► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014► Subscribe► 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
7,144,845Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
7,498,32117.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents► Subscribe
7,798,368Fluid dispensing device► Subscribe
6,537,983 Anti-inflammatory androstane derivatives► Subscribe
6,777,400 Anti-inflammatory androstane derivative compositions► Subscribe
6,777,399 Anti-inflammatory androstane derivative compositions► Subscribe
7,531,528Formulation 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
6,878,698 Anti-inflammatory androstane derivatives► 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
Norway338929► Subscribe
European Patent Office2363121► Subscribe
Spain2338312► Subscribe
European Patent Office1305329► Subscribe
Norway20064006► Subscribe
Japan2005519925► Subscribe
Singapore150524► Subscribe
MexicoPA05000821► Subscribe
Denmark1730676► Subscribe
EcuadorSP034470► 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
C011/2008Ireland► SubscribeSPC011/2008: 20081105, EXPIRES: 20230110
2008000029Germany► SubscribePRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
269Luxembourg► SubscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
2008 00022Denmark► Subscribe
C0014France► SubscribePRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
6Finland► Subscribe
1305329/01Switzerland► SubscribePRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
12/2008Austria► SubscribePRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE
429Luxembourg► Subscribe91429, EXPIRES: 20230111
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
McKinsey
Queensland Health
Deloitte
Farmers Insurance
US Army
Chubb
Mallinckrodt
Johnson and Johnson
AstraZeneca

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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