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Last Updated: April 22, 2024

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ARNUITY ELLIPTA Drug Patent 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 six patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-seven countries.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three 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 March 1, 2026. 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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARNUITY ELLIPTA
Generic Entry Date for ARNUITY ELLIPTA*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
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

ARNUITY ELLIPTA is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARNUITY ELLIPTA is ⤷  Try a Trial.

This potential generic entry date is based on INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ARNUITY ELLIPTA

Counter for use with a medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Manifold for use in medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ARNUITY ELLIPTA

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 205625-002 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ARNUITY ELLIPTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Avamys fluticasone furoate EMEA/H/C/000770
Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Authorised no no no 2008-01-11
Glaxo Group Ltd. Alisade fluticasone furoate EMEA/H/C/001019
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Withdrawn no no no 2008-10-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ARNUITY ELLIPTA

When does loss-of-exclusivity occur for ARNUITY ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05274296
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0514346
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 77248
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0528256
Estimated Expiration: ⤷  Try a Trial

Patent: 1084030
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17205
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 86498
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 86498
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 06169
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 28513
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 60868
Estimated Expiration: ⤷  Try a Trial

Patent: 08509766
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07001956
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 86498
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 86498
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0700851
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 61421
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 18278
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ARNUITY ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
South Africa 200300932 6.Alpha., 9.Alpha.-difluoro-17.Alpha.-'(2-furanylcaboxyl)oxy!-11.Beta.-hydroxy-16.Alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothioic acid s-fluoromethyl ester as an anti-inflamatory agent. ⤷  Try a Trial
United Kingdom 0108800 ⤷  Try a Trial
Poland 1651296 ⤷  Try a Trial
Spain 2435397 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg ⤷  Try a Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 LUC00077 Luxembourg ⤷  Try a Trial 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 ⤷  Try a Trial 91429, EXPIRES: 20230111
1305329 08C0014 France ⤷  Try a 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

Make Better Decisions: Try a trial or see plans & pricing

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.