ARNUITY ELLIPTA Drug Patent Profile

When do Arnuity Ellipta patents expire, and what generic alternatives are available?

Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA.

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

Summary for ARNUITY ELLIPTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	1,594
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 zero 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
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes

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	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	205625-002	Aug 20, 2014	5,873,360
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	7,629,335
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	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/000770Adults, 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/001019Adults, 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
Australia	645056
Argentina	032361	DERIVADOS DE ANDROSTANO Y SALES Y SOLVATOS DE LOS MISMOS, SU USO PARA LA FABRICACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN TALES COMPUESTOS, PROCESO PARA LA PREPARACION DE DICHOS COMPUESTOS, E INTERMEDIARIOS UTILES EN LA PREPARACION DE TALES COMPUESTOS
Malaysia	139577	ANTI-INFLAMMATORY ANDROSTANE DERIVATIVE
Slovenia	1775305
Taiwan	I455735

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
2506844	1890025-8	Sweden		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
1305329	CA 2008 00022	Denmark
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
2506844	LUC00077	Luxembourg		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

Market Dynamics and Financial Trajectory for ARNUITY ELLIPTA

Last updated: October 6, 2025

Introduction

ARNUITY ELLIPTA, marketed by GlaxoSmithKline (GSK), is an inhaled corticosteroid (ICS) indicated primarily for the management of asthma and chronic obstructive pulmonary disease (COPD). Launched amid a competitive landscape of respiratory therapies, ARNUITY ELLIPTA has carved out a distinctive niche due to its innovative delivery system and targeted therapeutic profile. The evolving market dynamics and financial trajectory of ARNUITY ELLIPTA reflect broader trends in respiratory disease management, intellectual property strategies, competitive pressures, and shifting healthcare priorities.

Market Overview

Respiratory Disease Market Growth

The global respiratory disease market, encompassing asthma and COPD, demonstrates a compounded annual growth rate (CAGR) estimated at 4-6% through 2030. Driven by rising prevalence rates, particularly among aging populations and urbanized regions, this segment offers significant revenue potential. According to IQVIA, the global asthma medication market was valued at approximately $15 billion in 2022, with an anticipated escalation facilitated by evolving treatment paradigms and increased diagnosis rates [1].

Key Therapeutic Competitors

ARNUITY ELLIPTA faces competitive pressure from a range of inhaled corticosteroids, combination therapies, and alternative delivery systems. Major players include AstraZeneca, Novartis, Teva, and Bayer, offering products such as Symbicort, Pulmicort, and Breo Ellipta. The competitive landscape emphasizes factors like device efficacy, dosing convenience, safety profiles, and patient adherence.

Positioning of ARNUITY ELLIPTA

ARNUITY distinguishes itself through the Ellipta inhaler device, which promotes ease of use, consistent dosing, and improved adherence. It is often positioned as an alternative or adjunct to existing ICS therapies, especially for patients demonstrating suboptimal control with other inhalers. Its differentiation relies heavily on device innovation and targeted patient education initiatives.

Market Penetration and Revenue Performance

Initial Launch and Adoption Trends

Since its approval, ARNUITY ELLIPTA experienced regulatory clearance in 2014 for asthma management. Initial adoption rates were modest, constrained by market inertia, prescriber familiarity, and limited physician education. However, over subsequent years, prescriptions have increased steadily, driven by expanding formulary coverage and evidence of clinical efficacy.

Revenue Trajectory

In 2022, ARNUITY ELLIPTA generated approximately $400 million globally, reflecting steady growth from launch volumes. Its sales trajectory has been supported by:

• Enhanced market penetration in the U.S. and European markets.
• Growing indication breadth, extending from pediatric to adult populations.
• Formulary inclusion, which boosts prescribing rates within integrated healthcare systems.

Despite this growth, ARNUITY's revenues trail behind market-leading inhalers like Fluticasone and combination products such as Advair and Breo Ellipta, necessitating continued focus on differentiated marketing strategies.

Market Dynamics Influencing Financial Trajectory

Regulatory and Reimbursement Environment

Regulatory policies in major markets favor the adoption of inhalers that demonstrate safety, efficacy, and ease of use. Payers increasingly scrutinize cost-effectiveness, impacting formulary placement. ARNUITY’s favorable safety profile and device innovation have facilitated reimbursement, though pricing pressures remain intense.

Patent and Intellectual Property Strategies

ARNUITY's core patents, covering formulation and device design, were granted in various jurisdictions but face challenges from generic competitors. Patent expirations, anticipated around 2026-2028, threaten to erode market share unless supplemented by new formulations or delivery innovations.

Market Penetration Strategies

GSK leverages targeted marketing campaigns, educational initiatives, and partnerships with healthcare providers to deepen its market share. Digital health tools and adherence monitoring further strengthen its position, especially post-COVID-19, as telehealth and remote patient management techniques gain prominence.

Emerging Market Opportunities

Emerging markets, notably in Asia-Pacific and Latin America, exhibit rising respiratory disease burdens. GSK has intensified efforts in these regions, adapting product pricing and coverage strategies to accelerate growth. These markets present a future revenue amplifier, offsetting stagnation in mature markets.

Impact of COVID-19 Pandemic

The COVID-19 pandemic has altered respiratory disease management, emphasizing telemedicine and reducing in-clinic prescriptions. While short-term disruptions impacted sales, increased focus on respiratory health has spurred longer-term growth prospects for inhalers like ARNUITY, especially as part of integrated disease management strategies.

Financial Forecasts

Short-term Outlook (Next 1-2 Years)

Revenue growth is projected to continue at a CAGR of approximately 4-6%, driven by increased prescriptions and expanded indications. GSK’s ongoing promotional efforts and formulary negotiations are expected to support this trajectory. New combination therapies and tailored patient programs also bolster sales.

Medium to Long-term Outlook (3-5 Years and Beyond)

Potential patent expirations pose risks, potentially causing revenue declines of 10-15% absent new innovations or line extensions. GSK’s pipeline includes next-generation inhalers and novel formulations aimed at sustaining long-term growth. Market expansion into emerging regions and growing disease prevalence reinforce optimistic projections.

Risks and Challenges

• Pricing pressures from payers and regulatory bodies.
• Patent cliffs leading to generic erosion.
• Competition from new inhaler technologies and biologics.
• Regulatory barriers impacting approval of new indications or formulations.

Strategic Implications

To optimize its financial trajectory, GSK must:

• Accelerate development of line extensions, including combination therapies.
• Strengthen digital health integration for improved adherence and patient outcomes.
• Expand presence in emerging markets through localized strategies.
• Invest in patient education and real-world evidence generation to bolster formulary acceptance.

Key Takeaways

• ARNUITY ELLIPTA operates in a dynamically growing respiratory market with increasing disease burden globally.
• Its differentiation hinges on device innovation and tailored patient management strategies.
• Revenue growth remains steady but must contend with patent expirations and intense competition.
• Strategic investments in pipeline development, regional expansion, and digital health will determine its future market standing.
• Regulatory and reimbursement environments significantly influence its financial trajectory, demanding adaptive strategies.

FAQs

1. How does ARNUITY ELLIPTA compare to its competitors in terms of efficacy?
ARNUITY ELLIPTA offers comparable efficacy to other inhaled corticosteroids but distinguishes itself through its delivery system, promoting better adherence. Clinical trials demonstrate non-inferiority to similar inhalers, with some evidence suggesting improved patient satisfaction.

2. What are the patent expiration risks associated with ARNUITY ELLIPTA?
Key patents relating to ARNUITY's formulation and device design are expected to expire by 2026-2028, potentially allowing generic competitors to enter the market with biosimilar or alternative formulations, impacting revenue.

3. How significant is the emerging markets segment for ARNUITY’s future growth?
Emerging markets represent a substantial opportunity due to rising respiratory disease incidence and expanding healthcare infrastructure. GSK’s tailored regional strategies can significantly boost future sales, especially if affordability barriers are addressed.

4. What role does digital health play in the market trajectory of ARNUITY?
Digital tools facilitate adherence monitoring and remote management, aligning with modern healthcare trends. Incorporating these technologies can improve treatment outcomes and patient retention, thereby positively impacting sales.

5. Are there upcoming innovations in ARNUITY’s pipeline?
Yes, GSK continues to develop next-generation inhalers and combination therapies that aim to improve efficacy, reduce side-effects, and enhance user experience, which could extend the product’s lifecycle and sustain revenue.

Sources

[1] IQVIA. “Global Respiratory Disease Market Report,” 2022.