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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has one hundred and ninety-nine patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

International Patents:	199
US Patents:	6
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

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
Parexel International Japan	Phase 3
GlaxoSmithKline	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

Paragraph IV (Patent) Challenges for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

International Patents for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Country	Patent Number	Title	Estimated Expiration
Ukraine	95768	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА;АНТАГОНІСТИ МУСКАРИНОВИХ РЕЦЕПТОРІВ АЦЕТИЛХОЛІНУ (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
European Patent Office	3335707	COMBINAISONS D'UN ANTAGONISTE DE RÉCEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RÉCEPTEUR BÊTA-2 ADRÉNERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
South Korea	20180128937
Lithuania	C2506844
Brazil	PI0619732
Morocco	33853	تركيبة مضاد استقبال المسكارينية ومحضر استقبال بتي ـ 2 الأدرينالية

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
1740177	C01740177/02	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
2506844	2018C/022	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1740177	570	Finland
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	C201830030	Spain		PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115

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

Last updated: February 19, 2026

What is the current market landscape for this combination therapy?

The triple combination therapy of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate is primarily used for managing chronic obstructive pulmonary disease (COPD). It entered the market after regulatory approval, primarily in 2018–2020. The drug operates within the respiratory segment, which maintains steady growth driven by rising COPD prevalence globally.

Market size and growth projections

• Global COPD therapeutics market was valued at approximately USD 13 billion in 2022.
• Anticipated compound annual growth rate (CAGR): 5.2% from 2023 to 2030 (MarketsandMarkets, 2023).
• Inhaled corticosteroids combined with long-acting beta-agonists and long-acting muscarinic antagonists (LABA/LAMA/ICS) represent a key subset, with the triple therapy accounting for an increasing share.

Sales by region (estimated 2022)

Region	Estimated Market Share	Revenue (USD billion)
North America	45%	6.2
Europe	27%	3.5
Asia-Pacific	20%	2.6
Rest of World	8%	1.0

Key players

• GlaxoSmithKline (GSK)
• Novartis
• AstraZeneca
• Boehringer Ingelheim

GSK's Trelegy Ellipta is the leading product, with sales exceeding USD 4 billion globally in 2022.

How do regulatory statuses affect market access?

The drug combination received regulatory approval mainly from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Approval was based on clinical trial data demonstrating improvements in lung function, exacerbation prevention, and symptom control.

• FDA approval: 2018
• EMA approval: 2019

Regulatory approval has expanded to multiple countries, supporting global market penetration.

What are the key factors influencing the financial trajectory?

Patent and exclusivity periods

• Original patents expire between 2023 and 2028, depending on jurisdictions.
• Patent expirations may lead to generic or biosimilar entry, affecting revenue.
• Patent filings for next-generation formulations or delivery devices could extend exclusivity.

Clinical trial landscape and pipeline development

Ongoing studies focus on efficacy, safety, and combination optimization.

• New formulations aiming at once-daily dosing
• Combination with other inhalation drugs for personalized therapy
• Inclusion in comprehensive COPD management guidelines

Pricing strategies and reimbursement policies

• High-cost therapies face reimbursement hurdles.
• Key markets like the U.S. and Europe rely heavily on insurance reimbursement.
• Price competition from biosimilars or generics is a risk post-patent expiry.

Market penetration and adoption

• Physicians prefer once-daily inhalers for adherence.
• Patient compliance improves with ease of use.
• Growing awareness and early diagnosis expand market size.

What future sales opportunities and risks exist?

Opportunity	Risk
Expansion into emerging markets	Patent cliffs and biosimilar competition
Developing next-generation inhalers	Pricing pressure post-generic entry
Increased adoption due to guideline updates	Regulatory delays or restrictions

Financial outlook estimates

• Sales growth expected to average 4–6% annually over the next five years.
• Peak market share for current formulations likely achieved by 2025, stabilized thereafter.
• Revenue reduction anticipated post-patent expiry unless new formulations or indications compensate.

Key Takeaways

• The combination product operates in a growing COPD market with steady demand.
• GSK's Trelegy Ellipta dominates sales but faces patent expiration starting in 2023.
• Regulatory approvals facilitated global expansion, with reimbursement policies shaping access.
• Innovation and pipeline development provide opportunities for revenue extension.
• Price competition and biosimilar entry pose significant revenue risks post-expiry.

FAQs

What factors most influence the market penetration of this drug?
Physician adoption driven by clinical efficacy, patient adherence due to ease of use, and reimbursement policies.

When do patent expirations typically occur for similar inhaled therapies?
Between 2023 and 2028, depending on jurisdiction and patent extensions.

Are biosimilars a threat to existing sales?
Yes. Biosimilar or generic competitors emerging after patent expiry can significantly reduce revenue.

What are the main regulatory hurdles?
Approval delays, safety concerns, and reimbursement restrictions in certain markets.

How does pipeline development affect financial prospects?
New formulations and indications can sustain or boost sales, offsetting patent expiries.

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Sources
[1] MarketsandMarkets. (2023). COPD Therapeutics Market.
[2] GSK. (2022). Trelegy Ellipta sales and pipeline information.
[3] U.S. Food and Drug Administration. (2018). Approval documentation for GSK COPD drugs.
[4] European Medicines Agency. (2019). Regulatory approval summaries.