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Last Updated: May 28, 2020

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ARNUITY ELLIPTA Drug Profile


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Which patents cover Arnuity Ellipta, and what generic alternatives 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 eighty-three patent family members in forty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Arnuity Ellipta

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ARNUITY ELLIPTA
Drug Prices for ARNUITY ELLIPTA

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Recent Clinical Trials for ARNUITY ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of VirginiaPhase 2
GlaxoSmithKlinePhase 3

See all ARNUITY ELLIPTA clinical trials

Recent Litigation for ARNUITY ELLIPTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

See all ARNUITY ELLIPTA litigation

Pharmacology for ARNUITY ELLIPTA
Synonyms for ARNUITY ELLIPTA
(6alpha,11alpha,14beta,16alpha,17alpha)-6,9-Difluoro-17-{[(Fluoromethyl)sulfanyl]carbonyl}-11-Hydroxy-16-Methyl-3-Oxoandrosta-1,4-Dien-17-Yl Furan-2-Carboxylate
(6alpha,11beta,16alpha,17alpha)-6,9-Difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate
397864-44-7
6alpha,9-Difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11beta-hydroxy-16alpha-methyl-3-oxoandrosta-1,4-dien-17alpha-yl furan-2-carboxylate
6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl 2-furoate
779352-12-4
911210-90-7
Alisade
Allermist
Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-17-((2- furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) ester, (6alpha,11beta,16alpha,17alpha)-
Avamys
Avamys pound>> Veramyst pound>> Allermist
BCP18136
BDBM50354851
CHEBI:74899
CHEMBL1676
D06315
DB08906
DTXSID60228586
Flonase Sensimist
Flonase Sensimist Allergy Relief
fluticason furoate
Fluticasone fuorate
Fluticasone furancarboxylate
Fluticasone furoate
Fluticasone furoate (JAN/USAN/INN)
Fluticasone furoate [USAN:INN]
fluticasonum furoas
FT-0668768
Furamist
furoate de fluticasone
furoato de fluticasona
GSK 685 698
GSK 685698
GSK-685968
GSK685968
GW 685698
GW 685698X
GW-685698
GW-685698X
GW6
gw685698
GW685698X
JS86977WNV
Q2166700
s6487
SCHEMBL140504
UNII-JS86977WNV
Veramyst
Veramyst (TN)
ZINC3992105

US Patents and Regulatory Information for ARNUITY ELLIPTA

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;INHALATION 205625-003 May 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ARNUITY ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014   Start Trial   Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 1890025-8 Sweden   Start Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731 13C0067 France   Start Trial PRODUCT 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
1305329 300343 Netherlands   Start Trial 300343, 20210803, EXPIRES: 20230110
1305329 91429 Luxembourg   Start Trial 91429, EXPIRES: 20230111
1305329 326 Finland   Start Trial
1305329 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
AstraZeneca
Dow
Baxter
Mallinckrodt

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 verification 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.