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Serving leading biopharmaceutical companies globally:

Citi
QuintilesIMS
Chinese Patent Office
US Army
Chubb
Harvard Business School
Cipla
Mallinckrodt
Deloitte
Farmers Insurance

Generated: November 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 four branded drugs marketed by Glaxosmithkline, Glaxosmithkline Cons, and Glaxo Grp Ltd, and is included in four 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 eighty-three patent family members in forty-one countries and twelve supplementary protection certificates in ten countries.

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

Pharmacology for 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 Cons
FLONASE SENSIMIST ALLERGY RELIEF
fluticasone furoate
SPRAY, METERED;NASAL022051-002Aug 2, 2016OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► SubscribeYY ► 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;INHALATION204275-002Apr 30, 2015RXYesYes► 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;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 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
7,531,528Formulation containing anti-inflammatory androstane derivatives► Subscribe
7,498,32117.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents► Subscribe
6,537,983 Anti-inflammatory androstane derivatives► Subscribe
6,777,399 Anti-inflammatory androstane derivative compositions► Subscribe
6,777,400 Anti-inflammatory androstane derivative compositions► Subscribe
6,878,698 Anti-inflammatory androstane derivatives► Subscribe
7,798,368Fluid dispensing device► Subscribe
6,858,593 Anti-inflammatory androstane derivative compositions► Subscribe
7,125,985Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
7,144,845Compounds 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
Australia2003244506► Subscribe
Denmark1868731► Subscribe
BrazilPI0514346► Subscribe
United Kingdom0019172► Subscribe
China101596335► Subscribe
BrazilPI0411773► Subscribe
Norway333467► Subscribe
Denmark1699512► Subscribe
World Intellectual Property Organization (WIPO)2005044354► Subscribe
United Kingdom0418278► 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
429Luxembourg► Subscribe91429, EXPIRES: 20230111
6Finland► Subscribe
C0014France► SubscribePRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 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
0343Netherlands► Subscribe300343, 20210803, EXPIRES: 20230110
C011/2008Ireland► SubscribeSPC011/2008: 20081105, EXPIRES: 20230110
12/2008Austria► SubscribePRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE
2008000029Germany► SubscribePRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
1305329/01Switzerland► SubscribePRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Novartis
Citi
QuintilesIMS
Cipla
Covington
UBS
Boehringer Ingelheim
Baxter
Express Scripts

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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