Fluticasone furoate; vilanterol trifenatate - Generic Drug Details

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

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.

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

Recent Clinical Trials for fluticasone furoate; vilanterol trifenatate

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
Q2 Solutions, LLC	Phase 3
BI Medical.Inc	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	204275-002	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	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	204275-001	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

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	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015

International Patents for fluticasone furoate; vilanterol trifenatate

Country	Patent Number	Title	Estimated Expiration
Cyprus	1121914
Denmark	2400950
Denmark	3578169
European Patent Office	2400950
European Patent Office	3578169
European Patent Office	4403231

Supplementary Protection Certificates for fluticasone furoate; vilanterol trifenatate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Fluticasone Furoate and Vilanterol Trifenatate: Market Dynamics, Patent Risk, and Financial Trajectory

Last updated: October 29, 2026

Fluticasone furoate/vilanterol trifenatate is a once-daily inhaled corticosteroid/long-acting beta2-agonist combination marketed by GSK as Breo Ellipta in the United States and Relvar Ellipta in many other markets. The product is approved for asthma and chronic obstructive pulmonary disease, but its commercial position is under pressure from generic inhaled combinations, competing single-inhaler therapies, pricing controls, and GSK’s strategic shift toward Trelegy Ellipta.

The combination remains commercially relevant because of once-daily dosing, the Ellipta inhaler platform, established physician familiarity, and its role in patients who require both inhaled corticosteroid and long-acting bronchodilator therapy. Its long-term financial trajectory is weaker than Trelegy’s because it lacks the additional long-acting muscarinic antagonist component that drives triple-therapy growth.

What is fluticasone furoate/vilanterol used for?

Fluticasone furoate/vilanterol combines:

• Fluticasone furoate, an inhaled corticosteroid that reduces airway inflammation.
• Vilanterol trifenatate, a long-acting beta2-adrenergic agonist that produces bronchodilation.

The product is delivered through the Ellipta dry-powder inhaler. The standard COPD and asthma strength contains 100 micrograms of fluticasone furoate and 25 micrograms of vilanterol. A higher 200/25 microgram strength is used for asthma in the United States.

Product	Active ingredients	Primary markets	Main indications
Breo Ellipta	Fluticasone furoate/vilanterol	United States	COPD and asthma
Relvar Ellipta	Fluticasone furoate/vilanterol	Europe and other markets	COPD and asthma
Trelegy Ellipta	Fluticasone furoate/umeclidinium/vilanterol	Global	COPD and asthma

The product is maintenance therapy. It is not a rescue inhaler and is not indicated for acute bronchospasm.

When did Breo Ellipta and Relvar Ellipta receive FDA approval?

The FDA approved Breo Ellipta for COPD in May 2013. The asthma indication followed in April 2015. GSK initially positioned the product as a once-daily alternative to twice-daily inhaled corticosteroid/LABA products such as Advair Diskus, which contains fluticasone propionate and salmeterol.

The FDA approved Trelegy Ellipta for COPD in 2017 and later expanded it to asthma. Trelegy created a higher-value product in the same Ellipta platform by adding umeclidinium, a long-acting muscarinic antagonist.

Regulatory event	Date	Commercial effect
FDA approval for COPD	May 2013	Established Breo in maintenance COPD
FDA approval for asthma	April 2015	Expanded the addressable market
Trelegy COPD approval	2017	Redirected GSK’s growth strategy toward triple therapy
Trelegy asthma expansion	2020	Increased substitution pressure within GSK’s portfolio

Sources: FDA, 2013; FDA, 2015; GSK, 2023.

How has the financial trajectory changed?

Breo/Relvar sales initially benefited from the shift toward once-daily inhalers and the maturity of the Ellipta platform. Growth later moderated as three forces developed:

1. Trelegy captured patients requiring escalation from dual therapy to triple therapy.
2. Generic and authorized-generic competition affected the broader ICS/LABA category.
3. Payers increased pressure on branded respiratory products.

GSK’s respiratory portfolio now depends more heavily on Trelegy, Nucala, and newer respiratory assets than on Breo/Relvar. GSK reports Breo and Relvar within its respiratory product reporting structure, while Trelegy has become one of the company’s principal growth brands.

Revenue exposure

The relevant commercial exposure has two levels:

• Direct exposure: sales of Breo Ellipta and Relvar Ellipta.
• Platform exposure: continued use of the Ellipta inhaler, physician familiarity, manufacturing infrastructure, and formulary relationships.

GSK’s respiratory revenue has continued to grow even as the relative importance of Breo/Relvar has declined. Trelegy has become the principal growth engine because it commands a higher-value position in COPD and asthma treatment. Breo therefore remains strategically important but is no longer the central driver of the respiratory franchise.

Commercial factor	Impact on Breo/Relvar
Once-daily dosing	Supports adherence and differentiation
Established Ellipta device	Supports physician and patient familiarity
Trelegy substitution	Reduces growth potential
Generic ICS/LABA competition	Increases price pressure
COPD maintenance demand	Provides a durable base
Asthma guideline shifts	Creates volume opportunities but increases competition
Payer contracting	Can preserve volume while reducing net price

What patents protect fluticasone furoate/vilanterol?

Protection for the product has historically involved several patent layers:

• Composition patents covering the combination of fluticasone furoate and vilanterol.
• Formulation patents covering the dry-powder blend.
• Inhaler-device patents covering the Ellipta platform.
• Manufacturing patents covering particle engineering, blending, and dose uniformity.
• Method-of-use patents covering treatment of COPD or asthma.

The most commercially relevant protection is the combination of drug-substance, formulation, and inhaler-device rights. A competitor may avoid one patent claim while remaining exposed to another. This is particularly important for inhaled products because equivalence depends on both pharmaceutical composition and device performance.

The FDA Orange Book historically listed patents for Breo Ellipta under NDA 204275. Relevant patent analysis must distinguish patents listed for the finished drug from patents covering the Ellipta device platform or other products in the GSK respiratory portfolio. Device patents may also be asserted outside the Orange Book framework.

Representative U.S. patent families associated with fluticasone furoate/vilanterol and related inhaled combinations include U.S. Patent Nos. 8,246,979 and 8,857,389. Their commercial relevance depends on claim scope, terminal disclaimers, patent-term adjustment, Orange Book listing status, and the specific ANDA formulation and device.

When does fluticasone furoate/vilanterol lose exclusivity?

The product’s effective exclusivity does not end on a single date. It declines in stages:

Exclusivity layer	Business significance
Regulatory exclusivity	Restricts certain FDA applications for a defined period
Composition patents	Can block a substantially identical combination
Formulation patents	Can block specific powder compositions
Device patents	Can complicate use of an equivalent inhaler
Method-of-use patents	May support claims for selected indications
Pediatric exclusivity	Can extend relevant patent or regulatory protection
Litigation settlements	May create a negotiated generic-entry date

For a small-molecule inhaled combination, the principal U.S. entry route is an ANDA with a Paragraph IV certification. A generic applicant must address listed patents and demonstrate pharmaceutical equivalence, device performance, and bioequivalence or an FDA-accepted alternative standard.

The practical loss of exclusivity depends on the earliest enforceable patent not removed through litigation, settlement, reexamination, post-grant proceedings, or claim construction. A nominal patent expiration date is therefore less useful than the effective generic-entry date.

Which companies are challenging Breo Ellipta?

Generic drugmakers have targeted branded inhaled corticosteroid/LABA products because of substantial respiratory demand and the high cost of branded inhalers. Companies active in respiratory generics or complex inhalation products include Teva, Sandoz, Viatris, Cipla, Lupin, and certain specialty inhalation manufacturers.

Paragraph IV litigation involving Breo Ellipta has centered on whether proposed products infringe formulation, composition, or device-related patents. Teva has been publicly associated with challenges involving GSK respiratory products, including Breo-related patents.

The competitive risk is higher than for a conventional oral tablet because an ANDA applicant must solve several technical problems:

• Matching the emitted dose.
• Matching particle-size distribution.
• Demonstrating consistent fine-particle delivery.
• Establishing device performance.
• Addressing combination-product requirements.
• Avoiding formulation and device patent claims.

These requirements raise development costs and can delay entry. They do not eliminate the risk of eventual generic competition.

What is the Orange Book status of Breo Ellipta?

Breo Ellipta is listed in the FDA Orange Book under NDA 204275. Orange Book-listed patents can trigger a 30-month stay when GSK files an infringement action within the statutory period after receiving a Paragraph IV notice.

The Orange Book is not a complete record of all intellectual-property risk. It generally does not capture every manufacturing patent, trade secret, device right, or nonlisted process claim. For Breo, the practical patent estate includes both listed patents and unlisted rights relating to inhaler manufacture, powder handling, and production controls.

GSK’s strongest commercial defenses are likely to be:

1. Formulation and blend uniformity.
2. Device design and dose delivery.
3. Manufacturing controls that are difficult to reproduce.
4. Patents with claims covering the specific combination rather than either active ingredient separately.

What formulation patents protect the product?

The formulation is a dry powder containing micronized active ingredients blended with an excipient, typically lactose-based carrier material. Patent claims may address:

• The ratio of active ingredients.
• Particle size and aerodynamic behavior.
• Carrier-particle structure.
• Moisture control.
• Blend homogeneity.
• Dose-metering performance.
• Stability during storage.
• Consistency across inhaler actuations.

These claims can have greater practical value than a broad composition claim when a generic applicant attempts to design around the original combination patent. A formulation can be chemically similar but still require a different blend, carrier, or device configuration to avoid infringement.

Manufacturing know-how is also material. Inhaled products require precise control of micronization, blending, humidity, filling, and device assembly. Process capability can create an entry barrier even after core composition patents expire.

Is there biosimilar risk for fluticasone furoate/vilanterol?

There is no conventional biosimilar risk. Fluticasone furoate and vilanterol are chemically defined small molecules, not biologic medicines.

The relevant threat is generic competition through the ANDA pathway. The product is a complex generic because equivalence involves an inhaled combination and a delivery device. FDA requirements can be more demanding than for an oral immediate-release product, but an approved generic would still receive substitution advantages depending on state law, payer policy, and formulary placement.

The absence of biosimilar risk does not mean the product is protected from competition. It means the competitive mechanism is generic substitution rather than biosimilar interchangeability.

How does Breo compare with Advair and Trelegy?

Product	Components	Dosing frequency	Strategic position
Advair	Fluticasone propionate/salmeterol	Usually twice daily	Mature, heavily genericized category
Breo/Relvar	Fluticasone furoate/vilanterol	Once daily	Branded dual therapy
Trelegy	Fluticasone furoate/umeclidinium/vilanterol	Once daily	Higher-value triple therapy

Breo’s advantages are once-daily dosing and a modern inhaler platform. Advair has greater historical familiarity but faces extensive generic competition. Trelegy has a stronger growth profile because it addresses patients who need triple therapy and is positioned as a step-up treatment in COPD and asthma.

The principal portfolio risk for Breo is internal substitution by Trelegy rather than direct substitution by Advair alone.

What litigation and settlement risks affect generic entry?

Generic-entry timing may be determined by:

• Paragraph IV notices.
• District-court infringement actions.
• Claim construction.
• Patent validity challenges.
• Inter partes review or other USPTO proceedings.
• Consent judgments.
• Authorized-generic arrangements.
• Settlement agreements with licensed launch dates.

A settlement can preserve a later generic launch while removing the uncertainty of litigation. It may also allow an authorized generic or other commercial arrangement. Public settlement terms are not always complete, and the business effect depends on launch date, royalty terms, product scope, and whether the agreement covers COPD, asthma, the device, or only a particular strength.

What is the commercial outlook?

The outlook is mature-to-declining for Breo/Relvar as a standalone growth brand, with continued cash generation from established demand. The most likely trajectory is:

• Stable or modestly declining branded volume before broad generic entry.
• Lower net pricing as payers negotiate against competing ICS/LABA products.
• Increasing internal migration to Trelegy among patients requiring escalation.
• Higher generic-entry risk as enforceable patent barriers narrow.
• Continued value from the Ellipta platform and GSK’s respiratory sales infrastructure.

The product remains commercially defensible where once-daily dosing, physician familiarity, and formulary access outweigh price differences. Its patent strength is best characterized as layered rather than absolute: formulation, device, and manufacturing rights can delay competition, but they do not provide the long-duration protection associated with a new chemical entity that has recently entered the market.

Key Takeaways

• Fluticasone furoate/vilanterol is marketed as Breo Ellipta in the United States and Relvar Ellipta internationally.
• FDA approvals cover COPD and asthma.
• GSK’s commercial strategy has shifted toward Trelegy Ellipta, which adds umeclidinium.
• The main competitive threat is generic ANDA entry, not biosimilar competition.
• Patent protection includes composition, formulation, device, manufacturing, and method-of-use layers.
• Inhaler equivalence and manufacturing controls create meaningful technical barriers.
• Orange Book patents are important but do not capture the entire commercial IP estate.
• Revenue should remain durable in the near term but is likely to face greater price and substitution pressure over time.
• Generic-entry timing will depend on Paragraph IV litigation, settlement terms, and the surviving enforceable patent claims.

FAQs

Is Breo Ellipta the same as Relvar Ellipta?

Yes. Breo Ellipta and Relvar Ellipta contain fluticasone furoate and vilanterol. The brand name differs by market.

Does fluticasone furoate/vilanterol have a generic equivalent?

Generic competition depends on FDA approval of an ANDA and resolution of applicable patents. The product is exposed to generic risk, but inhaler-device and formulation requirements can delay approval.

Is Breo Ellipta a biologic drug?

No. It contains chemically synthesized small molecules and is regulated as an inhaled drug combination, not as a biologic.

Can Breo Ellipta replace Trelegy Ellipta?

No. Breo contains an inhaled corticosteroid and LABA. Trelegy adds umeclidinium, a LAMA, and provides triple therapy.

What is the main investment risk for Breo Ellipta?

The main risks are generic entry, net-price erosion, payer restrictions, and substitution toward Trelegy or other triple-therapy products.

References

1. U.S. Food and Drug Administration. (2013). Breo Ellipta prescribing information.
2. U.S. Food and Drug Administration. (2015). Breo Ellipta: Supplemental new drug application approval for asthma.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
4. GlaxoSmithKline plc. (2023). Annual report 2023.
5. U.S. Patent and Trademark Office. (2024). Patent Center and patent term information.
6. U.S. Food and Drug Administration. (2024). Drugs@FDA: Breo Ellipta, NDA 204275.