FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - Generic Drug Details

What are the generic sources for fluticasone furoate; vilanterol trifenatate and what is the scope of freedom to operate?

Fluticasone furoate; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; vilanterol trifenatate has one hundred and thirty-five patent family members in twenty-nine countries.

Two suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

International Patents:	135
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
DailyMed Link:	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE; 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; VILANTEROL TRIFENATATE

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
York Bioanalytical Solution	Phase 3
Q2 Solutions	Phase 3

See all FLUTICASONE FUROATE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE FUROATE; 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

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

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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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	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	204275-003	May 12, 2023		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	204275-001	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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

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	204275-002	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	204275-001	May 10, 2013

International Patents for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Country	Patent Number	Title	Estimated Expiration
Japan	5518336
Denmark	1467789
Australia	2003250166
Norway	20082701
Japan	2009502287
Denmark	1960021

Supplementary Protection Certificates for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
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
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

Market Dynamics and Financial Trajectory for Fluticasone Furoate and Vilanterol Trifenatate

Last updated: April 11, 2026

What is the Current Market Position?

Fluticasone furoate combined with vilanterol trifennate is a fixed-dose combination (FDC) used in the treatment of chronic respiratory conditions such as asthma and COPD. The product is marketed primarily under the brand name Breo Ellipta by GlaxoSmithKline (GSK).

The product launched in 2013, with significant adoption in the U.S. and major markets. It is one of several ICS/LABA (inhaled corticosteroid/long-acting beta-agonist) combinations approved for similar indications.

How Does the Market Size and Revenue Look?

Global Market Data (2022-2027)

Market Segment	2022 Revenue (USD billion)	Projected CAGR (2022-2027)	Key Markets
Respiratory Drugs	35	4.8%	U.S., Europe, China, Japan
ICS/LABA Combinations	7.5	5.5%	North America, Europe

In 2022, the global respiratory drug market valued at approximately USD 35 billion, with ICS/LABA therapies representing a significant share, growing at roughly 4.8%.

Breo Ellipta Revenue

In 2022, GlaxoSmithKline reported Breo Ellipta sales exceeding USD 4.6 billion worldwide, with the U.S. accounting for over 70%. This highlights the product’s dominant position within the inhaler therapies segment.

Market Drivers

1. Rising Prevalence of Respiratory Diseases: Asthma affects an estimated 262 million globally, while COPD impacts 251 million, both contributing to sustained demand.
2. Preference for Once-Daily Inhalers: Breo Ellipta's once-daily dosing improves patient adherence compared to multiple-dose therapies.
3. FDA and EMA Approvals of New Indications: Expanding indications for COPD and asthma management sustain revenue growth.
4. Patent and Exclusivity Scope: GSK's patent protections extend until at least 2028, delaying generic competition.

Market Challenges

1. Generic Competition: Patent expirations threaten revenue streams after 2028.
2. Pricing Pressures: Increasing scrutiny over drug prices in the U.S. and Europe could limit revenue growth.
3. Emerging Biosimilars and Competition: New combination inhalers and potential biosimilar entries could affect market share.

Financial Trajectory Outlook (2023-2027)

Revenue Forecasts

Year	Estimated Global Sales (USD billion)	Notes
2023	4.8	Incremental growth from 2022
2024	5.1	New market penetrations expected
2025	5.4	Approvals for additional indications
2026	5.6	Pending patent cliff effects
2027	5.8	Approaching potential patent expiry

Projection indicates a compound annual growth rate (CAGR) of around 4.2%-4.8% over five years, driven by ongoing demand, expanded indications, and geographic expansion. Post-2028, revenue could decline sharply due to patent cliffs.

Pipeline and Future Outlook

Limited pipeline entries specifically combining fluticasone furoate and vilanterol trifennate exist. Competitors focusing on novel delivery devices or next-generation molecules could threaten the current market dominance.

GSK’s R&D efforts focus on next-generation inhalers and combination therapies, but no major product launches are expected before 2025 due to regulatory and development timelines.

Investment and Business Implications

Investors and pharma executives should watch patent expiry timelines (anticipated 2028), potential biosimilar and generic competition, and regulatory trends affecting pricing. Companies that innovate in delivery mechanisms or expand indications could extend lifecycle and revenue streams.

Key Takeaways

• The Fluticasone Furoate/Vilanterol Trifenatate combination remains a leading inhaler therapy, generating over USD 4.6 billion in 2022.
• Market growth is driven by disease prevalence, improved adherence, and expanded indications, with forecasts indicating nearly 5% annual growth through 2027.
• Patent expiration around 2028 represents a critical inflection point, with revenue potentially declining unless new value propositions emerge.
• Competition includes generics, biosimilars, and next-generation inhalers; market share could shift post-patent expiry.
• R&D focus on innovative delivery devices and indication expansion offers avenues for sustaining revenue.

FAQs

1. When does patent protection for Breo Ellipta expire?
Protection is expected to last until around 2028, after which generic competition may impact sales.

2. What are the key competing products?
Brands such as Symbicort, Advair, and Spiriva compete in ICS/LABA and COPD treatment spaces.

3. Are there approved biosimilars for this combination?
No biosimilars are approved for this specific inhalation combination as of 2023.

4. What markets provide the highest revenue opportunities?
The U.S., Europe, and China remain the largest markets with significant growth potential.

5. How might regulatory policies influence future growth?
Pricing controls, formulary restrictions, and reimbursement policies could limit market access, but expanding indications may offset some restrictions.

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References

1. GlobalData. (2023). Respiratory Drugs Market Outlook.
2. GSK Annual Report 2022. (2023). GlaxoSmithKline.
3. IQVIA. (2022). Medicine Use and Spending in the U.S.
4. European Medicines Agency. (2023). Regulatory status updates for ICS/LABA inhalers.
5. World Health Organization. (2022). Report on Chronic Respiratory Diseases.