TRELEGY ELLIPTA Drug Patent Profile

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

Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are ten patents protecting this drug.

This drug has two hundred and fifty-two patent family members in fifty-one countries.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trelegy Ellipta

Trelegy Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29, 2030. This may change due to patent challenges or generic licensing.

There have been six 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 TRELEGY ELLIPTA

International Patents:	252
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for TRELEGY ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRELEGY ELLIPTA
What excipients (inactive ingredients) are in TRELEGY ELLIPTA?	TRELEGY ELLIPTA excipients list
DailyMed Link:	TRELEGY ELLIPTA at DailyMed

See drug prices for TRELEGY ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRELEGY ELLIPTA

NDA:

209482

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 TRELEGY ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor Research Institute	Phase 4
GlaxoSmithKline	Phase 4

See all TRELEGY ELLIPTA clinical trials

Pharmacology for TRELEGY ELLIPTA

Drug Class	Anticholinergic Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for TRELEGY ELLIPTA

TRELEGY ELLIPTA is protected by eleven US patents.

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	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y

Expired US Patents for TRELEGY ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020

International Patents for TRELEGY ELLIPTA

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Ukraine

United Kingdom

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 TRELEGY ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
San Marino	T201800129
China	107412229	毒蕈碱受体拮抗剂和β‑2肾上腺素受体激动剂的组合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Japan	2013512270
Singapore	186597	MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS
Poland	2570128
South Korea	20080031458	MEDICAMENT DISPENSER
Poland	2170359

Supplementary Protection Certificates for TRELEGY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1305329	SPC011/2008	Ireland		SPC011/2008: 20081105, EXPIRES: 20230110
1740177	C01740177/02	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
1305329	C 2008 007	Romania		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
1425001	C01425001/01	Switzerland		PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
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
2506844	300942	Netherlands		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117

Market Dynamics and Financial Trajectory for TRELEGY ELLIPTA

Last updated: November 19, 2025

Introduction

TRELEGY ELLIPTA, a triple-combination inhaler developed by GlaxoSmithKline (GSK), represents a significant milestone in respiratory pharmacotherapy, particularly for chronic obstructive pulmonary disease (COPD) and asthma management. Its innovative formulation combines inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), and long-acting muscarinic antagonist (LAMA), offering a comprehensive treatment option. Understanding the market dynamics and the financial trajectory of TRELEGY ELLIPTA is pivotal for stakeholders, including investors, healthcare providers, and competitors, who seek to navigate the evolving landscape of respiratory medicines.

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Market Dynamics

1. Market Penetration and Growth Drivers

Since its launch, TRELEGY ELLIPTA has rapidly secured a prominent position within the inhaler market, driven by its convenience, efficacy, and approval for both COPD and asthma. Its once-daily dosing regimen appeals to patient preference, enhancing adherence and real-world effectiveness. According to IQVIA data, the inhaler market in the U.S. alone grew at a compound annual growth rate (CAGR) of approximately 6% from 2020 to 2022, with TRELEGY constituting a significant share of this expansion [1].

Key growth drivers include:

• Clinical Efficacy and Safety Profile: Robust clinical trials demonstrate its comparable or superior efficacy relative to monotherapies, with a favorable safety profile.
• Unmet Medical Need: Patients with severe COPD or uncontrolled asthma benefit from combination therapy, driving prescriber adoption.
• Regulatory Approvals: Expanded indications, including for asthma, have broadened its market reach.

2. Competitive Landscape

TRELEGY faces competition from several inhalers such as Spiriva (tiotropium), Symbicort (budesonide/formoterol), and Advair (fluticasone/salmeterol). While these primarily offer dual therapies, the trend toward triple therapy reflects a paradigm shift in COPD management, favoring medications like TRELEGY.

Major competitors include:

• Boehringer Ingelheim's combination inhalers
• AstraZeneca's triple therapy offering in development
• Generic and biosimilar entrants potentially impacting pricing dynamics

Market analysts project that the respiratory inhaler segment will experience high growth, with the triple therapy segment leading due to increased acceptance and evidence-based superiority [2].

3. Regulatory and Policy Influences

Regulatory agencies such as the FDA and EMA have accelerated approvals for inhalers demonstrating meaningful clinical benefits. Furthermore, cost-containment policies and formulary preferences influence prescribing patterns. TRELEGY's inclusion in major insurance formularies underscores its growing acceptance.

4. Geographic Expansion Potential

While North America and Europe currently dominate the sales footprint owing to high COPD prevalence and healthcare access, emerging markets—Asia-Pacific, Latin America, and Africa—are poised for rapid growth driven by rising respiratory disease burdens and expanding healthcare infrastructure.

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Financial Trajectory

1. Revenue Growth and Forecasts

Since its launch in 2017, TRELEGY has exhibited a robust revenue trajectory. GSK reports that in 2022, TRELEGY generated approximately £2.2 billion (~$3 billion), marking a year-over-year growth of around 21% [3]. The margin expansion is attributable to increased market penetration, optimized manufacturing, and pricing strategies.

Forecasts suggest that by 2028, TRELEGY’s global annual revenues could surpass £4 billion (~$5.4 billion), assuming continued adoption and expanding indications. The projected CAGR during this period is estimated at around 12–15%, reflecting steady growth but with potential acceleration driven by emerging markets and treatment guideline updates.

2. Pricing and Reimbursement Strategies

Pricing strategies vary across regions. In developed markets, premium pricing is supported by clinical benefits, though reimbursement negotiations influence net realizations. In competitive markets, discounts and negotiated rebates impact margins but facilitate broader access.

3. Investment in R&D and Pipeline Development

GSK continues investing in research for next-generation respiratory therapies and formulations. The pipeline includes fixed-dose combinations and devices aimed at improving drug delivery and adherence, which could further bolster TRELEGY’s financial prospects by extending its market life and enhancing therapeutic equivalence.

4. Challenges and Risks

Financial growth faces headwinds such as:

• Patent expirations: The primary patent protection for TRELEGY extends into the mid-2020s, after which biosimilar and generic competition could erode market share.
• Pricing pressures: Healthcare reforms and cost-containment policies threaten high-margin revenues.
• Regulatory hurdles: Approval of competing products or new treatment paradigms could impact market share.

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Strategic Outlook

GSK’s strategic focus involves expanding TRELEGY’s indications, such as for eosinophilic asthma, and investing in digital health integrations to support adherence. Furthermore, collaborations and licensing agreements hold potential to accelerate geographic expansion and reinforce market position.

Emerging biosimilars, combined with the ongoing digitization of respiratory health management, necessitate agile strategies to sustain growth trajectories. Cost-effective formulations, personalized medicine approaches, and targeted marketing will be critical in maintaining TRELEGY’s financial momentum.

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Key Takeaways

• Robust Market Position: TRELEGY ELLIPTA has established itself as a leading triple inhaler, capturing significant market share due to its efficacy, convenience, and broad indications.
• Impressive Revenue Trajectory: With revenues exceeding £2 billion in 2022 and projections indicating substantial growth, TRELEGY’s financial outlook remains optimistic amidst a competitive landscape.
• Growth Drivers: Clinical data, expanding indications, and regional penetration primarily propel growth, with emerging markets representing the next frontier.
• Competitive and Regulatory Risks: Patent expirations, biosimilar competition, and policy reforms pose challenges that require proactive strategic responses.
• Future Opportunities: Pipeline development, digital health integration, and access expansion in developing regions will be critical to sustaining growth.

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FAQs

1. What factors have contributed most to TRELEGY ELLIPTA’s market success?
Its convenient once-daily dosing, proven clinical efficacy, expansion into asthma indications, and strong regulatory support have driven adoption across healthcare markets.

2. How does TRELEGY compare with dual inhalers in terms of efficacy and patient adherence?
Clinical trials demonstrate superior or comparable efficacy of TRELEGY over dual therapies. Its simplified regimen improves adherence, which correlates with better disease control.

3. What are the main competitive threats facing TRELEGY in the coming years?
Patent expirations leading to biosimilar entry, aggressive pricing from competitors, and innovation in inhaler technology pose substantial threats.

4. How are emerging markets influencing TRELEGY’s financial outlook?
Growing respiratory disease burdens, expanding healthcare infrastructure, and increasing adoption of inhalers create significant revenue opportunities in the Asia-Pacific, Latin America, and Africa.

5. What strategic initiatives could enhance TRELEGY’s future growth?
Expanding indications, integrating digital health solutions, optimizing manufacturing costs, and strengthening regional distribution networks are key areas for growth.

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References

[1] IQVIA. Global Inhaler Market Report, 2022.
[2] MarketWatch. Respiratory Inhaler Market Outlook, 2023–2028.
[3] GSK Annual Report 2022. Financial Performance and Strategic Outlook.