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Last Updated: June 23, 2021

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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-four 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.

DrugPatentWatch® Generic Entry Outlook for Arnuity Ellipta

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 3, 2021. This may change due to patent challenges or generic licensing.

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

See drug prices for ARNUITY ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ARNUITY ELLIPTA
Generic Entry Date for ARNUITY ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Pharmacology for ARNUITY ELLIPTA

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   Get Started Free   Get Started Free Y Y   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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   Get Started Free   Get Started Free
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014   Get Started Free   Get Started Free
>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   Get Started Free 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
2506844 18C1022 France   Get Started Free PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
1305329 12/2008 Austria   Get Started Free PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111
1305329 C 2008 007 Romania   Get Started Free PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111
1305329 SPC011/2008 Ireland   Get Started Free SPC011/2008: 20081105, EXPIRES: 20230110
2506844 LUC00077 Luxembourg   Get Started Free PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1305329 91429 Luxembourg   Get Started Free 91429, EXPIRES: 20230111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
AstraZeneca
McKesson
Express Scripts
Mallinckrodt

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