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Last Updated: October 6, 2022

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 October 2, 2027. This may change due to patent challenges or generic licensing.

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

ARNUITY ELLIPTA is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARNUITY ELLIPTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Manifold for use in medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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: See Plans and Pricing

Brazil

Patent: 0514346
Estimated Expiration: See Plans and Pricing

Canada

Patent: 77248
Estimated Expiration: See Plans and Pricing

China

Patent: 0528256
Estimated Expiration: See Plans and Pricing

Patent: 1084030
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17205
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 86498
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 86498
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 06169
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28513
Estimated Expiration: See Plans and Pricing

Japan

Patent: 60868
Estimated Expiration: See Plans and Pricing

Patent: 08509766
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07001956
Estimated Expiration: See Plans and Pricing

Poland

Patent: 86498
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 86498
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0700851
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61421
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 18278
Estimated Expiration: See Plans and Pricing

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
European Patent Office 2348032 6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl) oxy]-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothiotic acid s-fluoromethyl ester comme agent anti-inflammatoire (6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl) oxy]-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothiotic acid s-fluoromethyl ester as an anti-inflammatory agent) See Plans and Pricing
France 2660550 See Plans and Pricing
Australia 2003266390 NOVEL CRYSTALLINE COMPLEXES See Plans and Pricing
China 1107687 See Plans and Pricing
Japan 2004505990 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 132013902182575 Italy See Plans and Pricing PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1305329 C 2008 007 Romania See Plans and Pricing 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
2506844 132018000000341 Italy See Plans and Pricing PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844 18C1022 France See Plans and Pricing 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 326 Finland See Plans and Pricing
>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

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.