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ARNUITY ELLIPTA Drug Profile

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Which patents cover Arnuity Ellipta, and what substitute generic drugs are available?

Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and thirty-nine patent family members in forty countries.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

Summary for Tradename: ARNUITY ELLIPTA

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list9
Clinical Trials: see list1
Patent Applications: see list501
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ARNUITY ELLIPTA at DailyMed

Pharmacology for Tradename: ARNUITY ELLIPTA

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, 2014RXYesYes7,101,866► SubscribeYY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes► Subscribe► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 2014RXYesYes8,113,199► SubscribeY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 2014RXYesYes7,629,335► SubscribeY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes8,113,199► SubscribeY ► Subscribe
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Expired Patents for Tradename: ARNUITY ELLIPTA

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 Tradename: ARNUITY ELLIPTA

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
6,858,596 Formulation containing anti-inflammatory androstane derivative► Subscribe
6,537,983 Anti-inflammatory androstane derivatives► Subscribe
7,592,329Crystalline complexes of fluticasone-2-furoate► Subscribe
6,777,400 Anti-inflammatory androstane derivative compositions► Subscribe
7,541,350Formulation containing 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 Tradename: ARNUITY ELLIPTA

Country Document Number Estimated Expiration
Japan5608197► Subscribe
Germany60308997► Subscribe
Denmark1730676► Subscribe
Israel188930► Subscribe
Denmark1651296► 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: ARNUITY ELLIPTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
429Luxembourg► Subscribe91429, EXPIRES: 20230111
C0014France► SubscribePRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
C011/2008Ireland► SubscribeSPC011/2008: 20081105, EXPIRES: 20230110
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
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