ARNUITY ELLIPTA Drug Patent Profile

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 three patents protecting this drug.

This drug has forty-six patent family members in twenty-one 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

Summary for ARNUITY ELLIPTA

International Patents:	46
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	2
Patent Applications:	1,431
Drug Prices:	Drug price information for ARNUITY ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARNUITY ELLIPTA
What excipients (inactive ingredients) are in ARNUITY ELLIPTA?	ARNUITY ELLIPTA excipients list
DailyMed Link:	ARNUITY ELLIPTA at DailyMed

See drug prices for ARNUITY ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

205625

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

Sponsor	Phase
University of Virginia	Phase 2
GlaxoSmithKline	Phase 3

See all ARNUITY ELLIPTA clinical trials

Pharmacology for ARNUITY ELLIPTA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ARNUITY ELLIPTA

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

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.

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	8,201,556		Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes	9,333,310*PED				Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes	8,201,556		Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes	9,333,310*PED				Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes	8,746,242*PED				Y

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	5,873,360
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	7,101,866
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018	7,101,866
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	7,101,866
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	5,873,360
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	7,629,335

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

International Patents for ARNUITY ELLIPTA

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

Country	Patent Number	Title	Estimated Expiration
Finland	107883
African Regional IP Organization (ARIPO)	1422	6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl)oxy!-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothioic acid s-fluoromethyl ester as an anti-inflammatory agent.
Austria	A43791
European Patent Office	1539796	COMPLEXES D'ANDROSTANE ANTI-INFLAMMATOIRES OU ANTI-ALLERGIQUES (ANTI-INFLAMMATORY OR ANTI-ALLERGIC ANDROSTANE COMPLEXES)
Yugoslavia	36791
South Korea	20070118317	6.ALPHA., 9.ALPHA.-DIFLUORO-17.ALPHA.-'(2-FURANYLCARBOXYL)OXY-11.BETA.-HYDROXY-16.ALPHA.-METHYL-3-OXO-ANDROST-1,4-DIENE-17-CARBOTHIOIC ACID S-FLUOROMETHYL ESTER AS AN ANTI-INFLAMMATORY AGENT

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	SPC011/2008	Ireland		SPC011/2008: 20081105, EXPIRES: 20230110
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	18C1022	France		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	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
1305329	326	Finland
1519731	132013902182575	Italy		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

Market Dynamics and Financial Trajectory for Arnuity Ellipta

Introduction

Arnuity Ellipta, a once-daily inhaled corticosteroid (ICS) containing fluticasone furoate, was approved by the FDA in 2014 for the maintenance treatment of asthma in patients aged 12 years and older. This article delves into the market dynamics and financial trajectory of Arnuity Ellipta, highlighting its positioning, cost analysis, and the broader financial performance of its manufacturer, GlaxoSmithKline (GSK).

Approval and Launch

The FDA approval of Arnuity Ellipta marked a significant milestone for GSK's respiratory portfolio. Darrell Baker, Senior Vice President & Head of GSK's Global Respiratory Franchise, emphasized the importance of this approval, noting it as the first asthma treatment from GSK's new portfolio to gain approval in the US[4].

Market Positioning

Arnuity Ellipta is part of GSK's expanding respiratory portfolio, which includes other notable products like Relvar/Breo Ellipta and Anoro Ellipta. The respiratory segment has been a key growth area for GSK, driven by the uptake of these new products[3].

Competitive Landscape

In the ICS market, Arnuity Ellipta competes with other established treatments such as fluticasone propionate (FP) and budesonide (BUD). The cost analysis submitted by the manufacturer indicates that while Arnuity Ellipta 100 mcg is more costly than low-dose ICSs, it offers cost savings compared to some medium-dose ICSs. Similarly, Arnuity Ellipta 200 mcg is more costly than some high-dose ICSs but offers savings relative to others[1].

Cost Analysis

The pharmacoeconomic review by the Common Drug Review (CDR) provides a detailed cost analysis of Arnuity Ellipta compared to other ICS treatments.

Cost Comparison

• Low-Dose ICSs: Arnuity Ellipta 100 mcg is more costly than low-dose ICSs.
• Medium-Dose ICSs: The cost of Arnuity Ellipta 100 mcg is comparable to or lower than some medium-dose ICSs, such as BUD 400 mcg.
• High-Dose ICSs: Arnuity Ellipta 200 mcg is more costly than BUD 400 mcg but offers savings compared to other high-dose ICSs like FP HFA 250 mcg and ciclesonide 200 mcg[1].

Financial Performance of GSK

Overall Revenue

GSK's financial performance has been robust, with significant contributions from its respiratory portfolio. In 2022, GSK reported total sales of £30.3 billion, with a 5% increase at constant exchange rates (CER) and 14% excluding COVID-19 solutions[5].

Respiratory Segment

The respiratory segment, which includes Arnuity Ellipta, has been a key driver of growth. In 2015, sales from new respiratory products, including Relvar/Breo Ellipta and Anoro Ellipta, reached £2 billion, helping to offset declines in older products like Seretide/Advair[3].

Operating Profit and EPS

GSK's operating profit and earnings per share (EPS) have shown significant growth. In 2022, the total continuing EPS was 110.8p, a 34% increase at AER and 18% at CER compared to 2021. This growth was driven by strong sales, beneficial mix, lower inventory adjustments, and higher royalty income[2].

Cash Flow and Investments

GSK has generated substantial cash from operations, which has been used to invest in research and development (R&D) and new product launches. In 2022, cash generated from operations was £7,944 million, with a significant portion allocated to R&D and acquisitions such as Sierra Oncology and Affinivax[2].

Future Outlook

GSK is poised for continued growth, with plans for at least 12 major launches from 2025, including new vaccines and specialty medicines for infectious diseases, HIV, respiratory, and oncology. This pipeline is expected to drive meaningful sales and earnings growth in the coming years[5].

Key Takeaways

• Market Approval: Arnuity Ellipta was approved by the FDA in 2014 for asthma treatment in patients aged 12 and older.
• Cost Analysis: It offers mixed cost savings compared to other ICS treatments, depending on the dose level.
• Financial Performance: GSK's respiratory segment, including Arnuity Ellipta, has contributed significantly to the company's overall revenue and growth.
• Future Growth: GSK is investing heavily in R&D and new product launches, positioning itself for continued growth in the pharmaceutical market.

FAQs

What is Arnuity Ellipta used for?

Arnuity Ellipta is used for the once-daily maintenance treatment of steroid-responsive bronchial asthma in patients aged 12 years and older[4].

How does Arnuity Ellipta compare to other ICS treatments in terms of cost?

Arnuity Ellipta 100 mcg is more costly than low-dose ICSs but offers cost savings compared to some medium-dose ICSs. Arnuity Ellipta 200 mcg is more costly than some high-dose ICSs but offers savings relative to others[1].

What has been the impact of Arnuity Ellipta on GSK's financial performance?

Arnuity Ellipta, as part of GSK's respiratory portfolio, has contributed to the company's revenue growth and helped offset declines in older products[3].

How is GSK positioned for future growth?

GSK is planning for at least 12 major launches from 2025, including new vaccines and specialty medicines, which is expected to drive significant sales and earnings growth[5].

What are the key drivers of GSK's operating profit and EPS growth?

Strong sales growth, beneficial mix, lower inventory adjustments, and higher royalty income have been key drivers of GSK's operating profit and EPS growth[2].

Sources

1. CDR Pharmacoeconomic Review Report for Arnuity Ellipta - Common Drug Review, December 2015.
2. GSK Full-year and fourth quarter 2022 results announcement - GSK, February 2023.
3. GSK Annual Report 2015 - GSK, March 2016.
4. GSK receives FDA approval for Arnuity™ Ellipta® - GSK, August 2014.
5. GSK Q4 2023 Announcement - GSK, January 2024.