Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

What are the generic drug sources for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate and what is the scope of patent protection?

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has two hundred and fifty-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

International Patents:	252
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate
DailyMed Link:	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Constraining patent/regulatory exclusivity:

9,750,726

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 fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
BI Medical.Inc	Phase 3
York Bioanalytical Solution	Phase 3

See all fluticasone furoate; umeclidinium bromide; vilanterol trifenatate clinical trials

Pharmacology for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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	209482-002	Sep 9, 2020		RX	Yes	Yes	7,439,393*PED				Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		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	8,309,572
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	8,534,281*PED				Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	8,534,281*PED				Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	8,183,257
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	7,488,827		Y	Y

Expired US Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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	7,776,895
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	7,629,335
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	209482-002	Sep 9, 2020	7,776,895
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017	8,183,257
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020	7,498,440

International Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Country	Patent Number	Title	Estimated Expiration
Hungary	E045371
Hungary	228508	PHENETHANOLAMINE DERIVATIVES AND PHARMACEUTICAL COMPOSITION CONTAINING THEM
Slovenia	1425001
Spain	2600405
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)
Brazil	112018069147	composto da fórmula iii, composição farmacêutica, método de inibição da função de fimh e método de tratamento de uma doença mediada por fimh
Portugal	2570128

Supplementary Protection Certificates for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	174 50004-2014	Slovakia		PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
1740177	2014/057	Ireland		PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	C 2014 041	Romania		PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428
1425001	C20140013 00103	Estonia		PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1740177	C01740177/03	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111

Market Dynamics and Financial Trajectory for Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate

Last updated: November 24, 2025

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Introduction

The combination drug comprising Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate (hereafter referred to as FF/Umecl/Vilanta) represents a strategically significant development within the respiratory pharmaceuticals sector. This triple therapy addresses chronic obstructive pulmonary disease (COPD) and asthma, aiming to improve patient outcomes through enhanced inhalation formulations. As the demand for effective inhaled therapies increases amidst aging populations and rising COPD prevalence globally, understanding its market dynamics and financial trajectory becomes paramount for stakeholders.

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Market Overview and Trends

Growing Prevalence of COPD and Asthma

The global burden of COPD and asthma underpins the growing market for inhaled therapies. According to the World Health Organization (WHO), COPD affects over 200 million individuals worldwide, with prevalence anticipated to rise driven by aging populations and environmental factors like pollution and tobacco use [1]. The increasing incidence directly correlates with heightened demand for advanced inhalation drugs, including combination therapies like FF/Umecl/Vilanta.

Advancement in Combination Drug Markets

Combination inhalers, especially triple therapies, are gaining prominence due to improved efficacy, reduced inhaler complexity, and better patient adherence. Regulatory approvals and clinical validations position these therapies favorably within both the COPD and asthma markets. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been approving progressively sophisticated combinations, fueling market expansion.

Competitor Landscape

Major pharmaceutical players such as GlaxoSmithKline (GSK), Novartis, AstraZeneca, and Boehringer Ingelheim dominate the inhaled therapy market, investing heavily in R&D for combination drugs. The presence of biosimilar options and generics further influences market pricing and accessibility. Notably, GSK’s Breo Ellipta, which contains Fluticasone Furoate and Vilanterol, exemplifies established competition with similar triple therapy formulations.

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Market Drivers

Rising R&D Investment and Clinical Efficacy

Continuous investment in research enhances drug efficacy and safety profiles, leading to increased clinician acceptance and prescription rates. Clinical trial results demonstrating improved lung function and reduced exacerbations significantly influence physician prescribing behaviors.

Regulatory Approval and Reimbursement Policies

Successful regulatory approvals and supportive reimbursement frameworks in North America, Europe, and parts of Asia underpin aggressive marketing strategies and price stability. Reimbursement coverage improves patient access, particularly in developed markets.

Innovation in Delivery Mechanisms

Advances in inhaler technology, such as dry powder inhalers (DPIs) with lower inhalation force requirements and improved drug delivery efficiency, enhance patient adherence. These innovations boost the appeal of combination therapies like FF/Umecl/Vilanta.

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Market Challenges

Pricing Pressures and Patent Expiry

Pricing pressures from payers, coupled with impending patent cliffs, threaten profit margins. The expiration of key patents can foster generic competition, necessitating strategic lifecycle management for sustained revenue.

Patient Adherence and Market Penetration

Despite clinical advantages, patient adherence remains a challenge. Multiple inhalers or complex regimens can reduce compliance, impacting overall market penetration for triple therapy formulations.

Regulatory Variability

Divergent regulatory standards and approval processes across jurisdictions can delay commercialization, influencing revenue timelines.

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Financial Trajectory and Future Projections

Revenue Forecasts

The global COPD drug market exceeded USD 12 billion in 2022 and is forecasted to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2030, driven by increasing disease prevalence and technological advancements [2].

Specifically, the triple therapy segment, including FF/Umecl/Vilanta, is expected to outpace the overall market due to its superior efficacy profile and convenience. Analysts project that by 2030, revenues from triple inhalers could constitute up to 30% of the COPD medication market, pushing past USD 5 billion globally.

Market Penetration Pathways

Revenue streams will depend on key factors such as regulatory approvals in emerging markets, successful marketing efforts, and strategic partnerships. The integration into treatment guidelines (e.g., GOLD criteria for COPD management) further accelerates adoption.

Strategic Opportunities and Risks

Big pharma firms are leveraging M&A to acquire robust product portfolios, potentially reduce R&D costs, and expand market reach. Conversely, patent expirations and emerging biosimilars pose risks to future revenue streams, demanding continuous innovation and strategic lifecycle planning.

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Investment and Commercialization Outlook

Investors and pharmaceutical companies should focus on:

• Regulatory milestones: Achieving approvals across vital markets, especially in Asia-Pacific.
• Clinical validation: Demonstrating superiority or non-inferiority to existing standards in phase III trials.
• Pricing and reimbursement strategies: Negotiating favorable terms to maximize market access.
• Pipeline development: Enhancing or combining existing formulations with new delivery technologies.

Expected timelines for global scale-up suggest that revenues could see a 10-20% annual growth rate over the next five years, contingent on regulatory success and market acceptance.

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Regulatory Environment and Patent Landscape

The drug’s patent protection status critically influences its financial trajectory. As patent exclusivities near expiration, strategic patent extensions and formulations innovations become pivotal. Regulatory bodies like the FDA and EMA continue to streamline processes for inhaled combination drugs, but approval hinges on demonstrating safety, efficacy, and quality.

The patent landscape remains competitive, with potential challenges from biosimilar entrants and generic manufacturers, especially in markets where patent protections lapse by mid-2020s. Proactive lifecycle management, including new indications and formulations, is thus vital to sustain profitability.

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Conclusion

The market for FF/Umecl/Vilanta is positioned for robust growth driven by increasing COPD and asthma prevalence, technological advances, and evolving treatment guidelines. While facing challenges such as pricing pressures, patent expirations, and market competition, strategic innovation, regulatory navigation, and market expansion can unlock substantial financial value. Stakeholders should adopt dynamic, evidence-driven strategies to capitalize on emerging opportunities within this expanding therapeutic niche.

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Key Takeaways

• Growing Demand: Increasing COPD prevalence globally ensures sustained need for effective combination inhalers like FF/Umecl/Vilanta.
• Market Growth: The triple inhaler segment is projected to grow at a CAGR of 4-6%, potentially reaching USD 5 billion by 2030.
• Competitive Landscape: Major players are investing in R&D and strategic collaborations to strengthen market positioning; patent cliffs and biosimilar threats necessitate lifecycle management.
• Regulatory and Reimbursement Impact: Rapid approvals and favorable reimbursement policies accelerate market penetration, particularly in North America and Europe.
• Innovation and Expansion: Incorporating novel delivery systems and expanding into emerging markets remain critical avenues for revenue growth.

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FAQs

1. What factors most significantly influence the market success of FF/Umecl/Vilanta?
   Clinical efficacy, regulatory approvals, patent protections, pricing strategies, and clinician acceptance are key determinants of market success.

2. How do patent expirations impact the financial trajectory of this drug?
   Patent expirations open the market to generics and biosimilars, typically lowering prices and eroding exclusivity-driven revenue streams, compelling firms to innovate or diversify.

3. What regulatory hurdles exist for expanding FF/Umecl/Vilanta into emerging markets?
   Variability in approval standards, data requirements, and registration timelines could delay launches; robust clinical data and local partnerships mitigate these risks.

4. How important are delivery technology advancements for the future marketability of this combination therapy?
   Significantly; enhanced inhaler devices improve adherence, efficacy, and patient satisfaction, directly impacting market adoption and revenue.

5. What role does health payer reimbursement play in the drug’s financial outlook?
   It is crucial; favorable reimbursement policies facilitate broader patient access, driving sales growth and ensuring competitive positioning.

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References

[1] World Health Organization. (2022). Global surveillance report on chronic respiratory diseases.
[2] MarketWatch. (2023). COPD Drugs Market Size, Share, Trends, and Forecast to 2030.