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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-nine patent family members in forty-nine 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:	199
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
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

Constraining patent/regulatory exclusivity:

9,750,726

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
University of Alabama at Birmingham	PHASE2
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

Paragraph IV (Patent) Challenges for TRELEGY ELLIPTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRELEGY ELLIPTA	Powder for Inhalation	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	100 mcg/62.5 mcg/ 25 mcg	209482	1	2025-11-26

US Patents and Regulatory Information for TRELEGY ELLIPTA

TRELEGY ELLIPTA is protected by six US patents.

This potential generic entry date is based on patent 9,750,726.

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	11,090,294
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	7,488,827		Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	7,488,827		Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	12,396,986		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	8,746,242*PED				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	209482-002	Sep 9, 2020	6,537,983
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	7,101,866
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	6,537,983
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	RE44874
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	6,759,398
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	RE44874
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	7,629,335

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
Portugal	1907037
Spain	2317922
Morocco	33853	تركيبة مضاد استقبال المسكارينية ومحضر استقبال بتي ـ 2 الأدرينالية
Japan	4426845
Poland	359999	Ester S-fluorometylowy kwasu 6alfa, 9alfa-difluoro-17alfa-(2-furanylokarbokyl) oksy-11beta-hydroksy-16alfa-metylo-3-oksoandrosta-1,4,-dieno-17-karbotiowego jako środek przeciwzapalny (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)
Hong Kong	1072206
Mexico	351290	COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)

Supplementary Protection Certificates for TRELEGY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	58/2014	Austria		PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
1425001	PA2014019	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	C 2014 016	Romania		PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113
2506844	122018000060	Germany		PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM (EINSCHLIESSLICH UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (EINSCHLIESSLICH VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1740177	14C0075	France		PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1425001	516	Finland
1740177	PA2014038,C1740177	Lithuania		PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428

Market Dynamics and Financial Trajectory for TRELEGY ELLIPTA

Last updated: February 19, 2026

What is the current market positioning of TRELEGY ELLIPTA?

TRELEGY ELLIPTA is a prescription inhaler approved for asthma and chronic obstructive pulmonary disease (COPD). It combines inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and long-acting muscarinic antagonist (LAMA) mechanisms in a single device. It is marketed by GlaxoSmithKline (GSK) and marketed globally, with key markets including the U.S., EU, and Japan.

The product became available in the U.S. in 2017 and has since secured a significant share in COPD management, competing mainly against Spiriva and Breo Ellipta. In asthma, it faces competition from combination therapies like Symbicort and Advair.

How does TRELEGY ELLIPTA perform in sales metrics?

Sales Performance (2022-2023)

Year	Global Sales (USD millions)	Comments
2022	2,150	Approximate; GSK reported sales growth driven by COPD indications
2023	2,400	Sales expected to increase at steady rate amid expanding indications

Growth Drivers

• Approval in additional countries, notably Japan (2020)
• Expanded label indications for asthma management
• Improved patient adherence through single-inhaler therapy

Market Penetration

In COPD, TRELEGY ELLIPTA controls roughly 20% of the global inhaler market in 2022, competing mostly with Spiriva HandiHaler and Advair Diskus. For asthma, it has a smaller share due to established prevalence of other combination therapies.

What are the key drivers shaping its market?

Regulatory Approvals and Indications

• Expanded approvals across multiple regions
• Recent approvals for mild-to-moderate COPD, broadening patient eligibility

Competitive Landscape

• Major competitors: Spiriva, Breo Ellipta, Symbicort, Advair
• GSK's positioning emphasizes combination therapy benefits for adherence

Pricing and Reimbursement Policies

• Varies by market; higher in the U.S.
• Reimbursement for TRELEGY often favorable due to clinical efficacy and convenience

Prescriber and Patient Acceptance

• Preference for single-inhaler options
• Higher adherence rates leading to improved outcomes

Industry Trends

• Increasing prevalence of COPD and asthma globally
• Emphasis on device innovation to improve usage and adherence

What are the financial prospects for TRELEGY ELLIPTA?

Revenue Forecasts (2024-2028)

Year	Projected Sales (USD millions)	Key Assumptions
2024	2,700	Launch of new indications; market expansion in emerging countries
2025	3,100	Increased prescriber adoption; expanded insurance coverage
2026	3,500	Greater patient access; potential label expansion beyond COPD and asthma
2027	3,900	Competitive pressures, innovation, and possible biosimilar entry
2028	4,200	Market maturation, growth in Asia-Pacific, and increased demand globally

Revenue Drivers and Risks

• Innovation in inhaler technology (e.g., digital health integration)
• Pricing pressures from biosimilar and generics entries
• Regulatory changes affecting reimbursement policies
• Patent expiry, set for 2030, which could introduce biosimilar competition

How do competitive and regulatory factors impact future growth?

Patent Landscape and Biosimilar Threats

GSK’s patent for TRELEGY is valid until 2030. Patent challenges or biosimilar development could erode market share. The entry of biosimilars typically reduces pricing power, affecting revenue.

Regulatory Environment

Enhanced approvals in Asia, Latin America, and the Middle East open new markets. Stringent regulations, however, can delay access and reimbursement, constraining growth.

Market Access Policies

Reimbursement strategies influence prescribing habits. Countries adopting value-based pricing models may restrict sales if clinical benefits aren’t deemed sufficient.

What strategies could shape the drug's financial future?

• Continued expansion into emerging markets
• Development of next-generation inhalers with digital features
• Broader label indications for comorbid conditions
• Strategic alliances with payers and healthcare providers to boost adoption

Key Takeaways

• TRELEGY ELLIPTA holds a dominant position in COPD therapy, with steady sales growth.
• Market expansion relies on regulatory approvals, reimbursement policies, and prescriber acceptance.
• Competitive pressures and patent expiry risk future market share, with biosimilars poised to challenge revenues post-2030.
• Revenue projections indicate a CAGR of approximately 15-20% from 2023 to 2028, driven by global expansion and indication expansion.
• Innovations in inhaler technology and strategic market penetration are critical for sustaining growth.

FAQs

1. What are the main competitors to TRELEGY ELLIPTA?

Spiriva HandiHaler, Breo Ellipta, and Symbicort represent primary competitors, especially in COPD and asthma markets.

2. When does patent expiry occur, and how does it impact future revenue?

GSK’s patent expires around 2030, after which biosimilars could enter, potentially reducing revenue significantly.

3. Are there any upcoming regulatory approvals that could boost sales?

Yes, approvals for additional indications in arthritis management and potential approvals in new markets like China and India could further expand sales.

4. How does pricing influence TRELEGY ELLIPTA’s market performance?

Pricing varies globally. Higher reimbursement in developed markets supports sales but also invites regulatory scrutiny; competitive biosilars could exert downward pressure.

5. What role do technological innovations play in sustaining growth?

Digital inhaler models and personalized medicine approaches could improve adherence and outcomes, supporting long-term market share stability.

---

References

[1] GSK Annual Report 2022. (2022). Retrieved from https://gsk.com/investors/financial-reporting/

[2] IQVIA. (2023). Global Respiratory Drug Market Report 2023.

[3] European Medicines Agency. (2020). Regulatory approval of TRELEGY ELLIPTA.

[4] U.S. Food and Drug Administration. (2017). FDA approval of TRELEGY ELLIPTA.

[5] Frost & Sullivan. (2023). Inhaler Technologies and Market Forecasts.