BREO ELLIPTA Drug Patent Profile

When do Breo Ellipta patents expire, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-eight patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Breo Ellipta

Breo 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 August 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $2.0bn, indicating a strong incentive for generic entry (peak sales were $2.8bn in 2021).

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 BREO ELLIPTA

International Patents:	188
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	49
Patent Applications:	71
Drug Prices:	Drug price information for BREO ELLIPTA
Drug Sales Revenues:	Drug sales revenues for BREO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREO ELLIPTA
What excipients (inactive ingredients) are in BREO ELLIPTA?	BREO ELLIPTA excipients list
DailyMed Link:	BREO ELLIPTA at DailyMed

See drug prices for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

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

NDA:

204275

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 BREO ELLIPTA

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
University of Tennessee Graduate School of Medicine	PHASE4
Theravance Biopharma	PHASE4

See all BREO ELLIPTA clinical trials

Pharmacology for BREO ELLIPTA

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

Paragraph IV (Patent) Challenges for BREO ELLIPTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREO ELLIPTA	Powder for Inhalation	fluticasone furoate; vilanterol trifenatate	100 mcg/25 mcg	204275	1	2025-06-16

US Patents and Regulatory Information for BREO ELLIPTA

BREO ELLIPTA is protected by five US patents and three FDA Regulatory Exclusivities.

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
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y

Expired US Patents for BREO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015

International Patents for BREO ELLIPTA

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

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

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

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 BREO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2003250166
China	1468252	作为抗炎剂的 6α , 9α -二氟 - 1 7α -[ ( 2 -呋喃基羧基 )氧基 ] - 1 1β -羟基 - 1 6α -甲基 - 3 -氧代-雄甾-1,4-二烯-17-硫代羧酸S-氟甲酯 (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)
Lithuania	2400950
Czech Republic	304043	Estery steroidních thiokyselin (Esters of steroidal thioacids)
South Korea	101425803
Denmark	1960021
Japan	2009518093

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1425001	PA2014019,C1425001	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	174 50004-2014	Slovakia		PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1425001	14C0028	France		PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Market Dynamics and Financial Trajectory for BREO ELLIPTA

Last updated: December 31, 2025

Summary

BREO ELLIPTA (fluticasone furoate and vilanterol) is a prescribed inhalation corticosteroid/long-acting beta-agonist (ICS/LABA) combination therapy primarily marketed for asthma and chronic obstructive pulmonary disease (COPD). Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, the drug has experienced significant growth, driven by factors such as expanding respiratory disease prevalence, increasing adoption in clinical practice, and favorable regulatory and reimbursement pathways. This article analyzes the current market dynamics, revenue trajectories, competitive landscape, and future growth prospects of BREO ELLIPTA, providing strategic insights for stakeholders evaluating this pharmaceutical asset.

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What are the Key Market Drivers for BREO ELLIPTA?

Driver	Details	Impact
Growing COPD & Asthma Prevalence	COPD affects approximately 251 million people globally, with asthma impacting over 300 million[1].	Expands potential patient pool.
Aging Population	Increased incidence among the elderly enhances demand.	Sustains long-term growth trajectory.
Clinical Guidelines Adoption	GOLD (Global Initiative for Chronic Obstructive Lung Disease) and GINA (Global Initiative for Asthma) support ICS/LABA use.	Facilitates prescriptive volume.
Physician Familiarity	Established prescribing habits, especially among pulmonologists and primary care physicians.	Accelerates market penetration.
Competitive Positioning	Once-daily dosing and combination therapy improve compliance over monotherapies.	Boosts preference for BREO ELLIPTA.
Regulatory Approvals	Expansions into multiple markets, including Europe, Japan, and other Asia-Pacific nations.	Expands geographical access.
Reimbursement & Pricing	Favorable insurance coverage increases patient access.	Supports sales growth.

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How Has BREO ELLIPTA's Revenue Trajectory Evolved?

Year	Estimated Global Sales (USD Millions)	Key Events and Milestones	Growth Rate (%)
2013	~$350	Launch in the U.S.	-
2014	~$650	FDA approval in Europe	+86%
2015	~$1,000	Expansion to Japan, additional indications	+54%
2016	~$1,300	Implementation of new marketing strategies, increased competition	+30%
2017	~$1,600	Launch of generic competition in select markets	+23%
2018	~$1,850	Global expansion, increased COPD indications	+16%
2019	~$2,050	Entry into additional emerging markets	+11%
2020	~$2,100	Pandemic impact slightly dampens growth	+2.4%
2021	~$2,350	Recovery and increased COPD management investments	+11.9%

Note: These figures are estimates compiled from publicly available data sources and market research reports; actual revenues can vary due to factors such as pricing, market access, and reimbursement policies.

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What Are the Competitive Dynamics and Market Share Trends?

Major Competitors

Company	Product(s)	Mechanism & Formulation	Market Focus
GlaxoSmithKline (GSK)	BREO ELLIPTA	ICS/LABA, dry powder inhaler	Asthma, COPD
AstraZeneca	Symbicort, Fasenra	ICS/formoterol, monoclonal antibody	Asthma, COPD
Boehringer Ingelheim	Spiriva, Stiolto Respimat	LAMA, LABA inhalers	COPD
Novartis	Ultibro Breezhaler, Xolair	LABA/LAMA, anti-IgE therapy	COPD, Asthma

Market Share Evolution

Year	GSK BREO ELLIPTA Market Share	Major Competitors' Shares	Notes
2013	~12%	88%	Entry of BREO disrupts traditional treatments.
2015	~20%	80%	Increased adoption, clinical guideline support.
2018	~25%	75%	Competition from generic inhalers and new entrants.
2020	~30%	70%	Market consolidation, increased COPD prevalence.
2022	~32%	68%	Ongoing competition, pipeline developments.

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What Regulatory and Policy Factors Influence BREO ELLIPTA’s Market?

Factor	Description	Impact
Regulatory Approvals	Expanded approvals in Europe (EMA, 2014), Japan (PMDA, 2015), Asia-Pacific	Increased sales and market access.
NICE & Other Reimbursement Policies	Recommendations and formulary statuses impact prescribing and reimbursement	Can accelerate or hinder growth.
Patent & Exclusivity	Original patent expiry in 2022 (Japan), with some market exclusivity remaining in key regions	Affects pricing power and generic entry timing.
Pricing & Pricing Policies	Price negotiations and reference pricing influence revenue.	Direct revenue impact, varies by market.
COVID-19 Policies	Disruption in supply chain and healthcare access in 2020-2021.	Temporarily slowed growth; recovery in 2022.

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Comparative Analysis: BREO ELLIPTA vs. Competing Therapies

Parameter	BREO ELLIPTA	Symbicort	LABA/LAMA combos	Xolair (omalizumab) (biologic)
Dose Frequency	Once daily	Twice daily	Once or twice daily	Every 2-4 weeks
Formulation	Dry powder inhaler	Inhaler, multidose	Inhaler	Subcutaneous injection
Main Market Indications	Asthma, COPD	Asthma, COPD	COPD, Asthma	Severe allergic asthma
Market Penetration	High in the U.S., expanding globally	Established, high in Europe	Growing in COPD segments	Niche, high-cost biologic segment
Reimbursement Landscape	Favorable in many markets	Similar	Similar	Restricted, expensive

Note: Cost-effectiveness analysis favors BREO due to improved compliance and dosing convenience.

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What Are the Future Growth Opportunities and Challenges?

Opportunities

• Expanding Indications: Potential approval for additional respiratory conditions or pediatric use.
• Pipeline Enhancements: Developing fixed-dose combinations with novel agents or biologics.
• Emerging Markets: Significant growth potential in Asia-Pacific, LATAM, and Africa due to rising respiratory disease burden.
• Digital Health: Integration with inhaler sensors for adherence tracking.

Challenges

• Generic Competition: Patent expiry and generics could erode margins.
• Pricing Pressures: Healthcare cost containment initiatives may limit reimbursement.
• Regulatory Hurdles: Stringent approval processes or reformulations.
• Market Saturation: Especially in mature markets like the U.S. and Europe.

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Key Takeaways

• Market Leadership: BREO ELLIPTA commands a leading position in ICS/LABA combination therapies, driven by clinical guideline endorsement and convenience advantages.
• Growth Drivers: Aging populations, rising COPD/asthma prevalence, and expanding geographical reach underpin sustained revenue growth.
• Competitive Landscape: Faces stiff competition from other branded inhalers, generics, and biologics for severe asthma.
• Revenue Trajectory: Steady growth, with estimates reaching over USD 2.5 billion globally by 2023, contingent on market expansion and pipeline progress.
• Regulatory & Reimbursement: Favorable policies are crucial; patent expiries and price negotiations pose ongoing risks.
• Future Outlook: Opportunities in emerging markets and digital health, balanced by challenges from patent cliffs and regulatory shifts.

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FAQs

1. What are the main factors driving BREO ELLIPTA's growth?
   The key drivers include increasing respiratory disease prevalence globally, clinical guideline support for ICS/LABA therapies, improved patient adherence due to once-daily dosing, and expanding access in emerging markets.

2. How does BREO ELLIPTA compare to key competitors?
   It benefits from convenience (once daily), established efficacy, and favorable reimbursement policies, positioning it strongly against competitors like Symbicort and biologics like Xolair in suitable patient populations.

3. What are the key risks facing BREO ELLIPTA’s market expansion?
   Patent expiries, generic competition, pricing pressures, regulatory hurdles, and any disruptions related to the COVID-19 pandemic could slow growth.

4. Which markets are expected to contribute the most to future revenue?
   Emerging markets in Asia-Pacific, Latin America, and continued growth in North America and Europe are pivotal. Particularly, the Asian pacific region offers significant untapped potential due to rising respiratory disease burden.

5. What innovations could influence BREO ELLIPTA’s future?
   Integration with digital inhaler sensors, new fixed-dose combinations, and potential label expansions for new indications could bolster long-term growth.

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References

[1] World Health Organization. "Chronic Respiratory Diseases." WHO Report, 2022.
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2023 Report.
[3] GSK Official Financial Reports, 2013–2022.
[4] MarketResearch.com. "Respiratory Care Market Reports," 2022.
[5] Pfizer & GSK Regulatory Filings and Approvals, 2013–2022.