Fluticasone furoate - Generic Drug Details

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

Fluticasone furoate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Haleon Us Holdings, and Glaxo Grp Ltd, and is included in four NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate has one hundred and twenty patent family members in twenty-three countries.

There are five drug master file entries for fluticasone furoate. Four suppliers are listed for this compound.

Summary for fluticasone furoate

International Patents:	120
US Patents:	15
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	161
Drug Prices:	Drug price trends for fluticasone furoate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate
What excipients (inactive ingredients) are in fluticasone furoate?	fluticasone furoate excipients list
DailyMed Link:	fluticasone furoate at DailyMed

See drug prices for fluticasone furoate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fluticasone furoate

Constraining patent/regulatory exclusivity:

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971

Dosage:

POWDER;INHALATION

Constraining patent/regulatory exclusivity:

8,347,879

Dosage:

SPRAY, METERED;NASAL

^*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

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

Sponsor	Phase
Western University, Canada	PHASE4
Thammasat University	PHASE4
Mahidol University	PHASE3

See all fluticasone furoate clinical trials

Pharmacology for fluticasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone furoate

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLONASE SENSIMIST ALLERGY RELIEF	Nasal Spray	fluticasone furoate	27.5 mcg	022051	1	2011-07-15

US Patents and Regulatory Information for fluticasone furoate

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	12,396,986		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		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	8,534,281*PED				Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	7,439,393*PED				Y

Expired US Patents for fluticasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	7,101,866
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	7,629,335
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	6,858,596
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018	7,101,866
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	7,101,866

EU/EMA Drug Approvals for fluticasone furoate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Avamys	fluticasone furoate	EMEA/H/C/000770Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.	Authorised	no	no	no	2008-01-11
Glaxo Group Ltd.	Alisade	fluticasone furoate	EMEA/H/C/001019Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.	Withdrawn	no	no	no	2008-10-06

International Patents for fluticasone furoate

Country	Patent Number	Title	Estimated Expiration
Spain	2376104
United Kingdom	0219462
European Patent Office	1501576	DISPOSITIF DE DISTRIBUTION DE FLUIDE (A FLUID DISPENSING DEVICE)
European Patent Office	1501575	DISPOSITIF DE DISTRIBUTION DE FLUIDE (A FLUID DISPENSING DEVICE)
Denmark	1699512

Supplementary Protection Certificates for fluticasone furoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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	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	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 Fluticasone Furoate

Last updated: September 24, 2025

Introduction

Fluticasone furoate, a potent inhaled corticosteroid (ICS), plays a pivotal role in managing allergic rhinitis, chronic obstructive pulmonary disease (COPD), and asthma. Since its introduction, it has gained significant market traction due to its efficacy and safety profile. This analysis explores the market dynamics surrounding fluticasone furoate and projects its financial trajectory, offering critical insights for stakeholders involved in development, manufacturing, and commercialization.

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Pharmacological Profile and Therapeutic Indications

Fluticasone furoate (marketed under brands such as Breo Ellipta and Avamys) demonstrates anti-inflammatory action pivotal in reducing airway hyperresponsiveness. Its high receptor affinity and favorable pharmacokinetics distinguish it from other ICS, facilitating once-daily dosing that enhances patient adherence (as noted in clinical pharmacology studies [1]).

Indications include:

• Asthma management
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis

The versatility across respiratory disorders amplifies its market presence and growth potential.

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Market Dynamics

1. Competitive Landscape

The respiratory drug market is saturated with synthetic corticosteroids, notably fluticasone propionate (used in Flonase, Flovent). Fluticasone furoate's unique high receptor affinity and improved pharmacodynamics have enabled it to carve out a niche, especially in combination therapies (e.g., with vilanterol in Breo Ellipta). Key competitors include budesonide, mometasone, and beclomethasone, but fluticasone furoate’s once-daily regimen offers adherence advantages.

Market penetration is bolstered by:

• Extended patent protections, providing exclusive marketing rights
• New product formulations targeting specific populations (pediatric, elderly)
• Post-marketing research expanding indications

2. Regulatory Environment

Regulatory agencies like the FDA and EMA have approved several fluticasone furoate formulations, with ongoing trials exploring additional uses. Patent protections, combined with regulatory exclusivity, have delayed generic entry in key markets [2]. Patent expirations projected in the next 3-5 years threaten generic competition, potentially eroding margins.

3. Market Drivers

• Rising prevalence of respiratory conditions, driven by pollution, urbanization, and smoking habits
• Growing awareness of inhaler adherence importance
• Development of combination therapies improving patient outcomes

4. Market Challenges

• Patent cliffs leading to generic competition
• Price pressures from payers
• Stringent regulatory requirements for new indications
• Potential side effect concerns associated with corticosteroids, affecting perceived safety profiles

5. Regional Market Trends

• North America remains the dominant market, fueled by high disease prevalence and healthcare expenditure.
• Asia-Pacific exhibits rapid growth, attributed to increasing diagnosis rates and expanding healthcare infrastructure.
• Europe maintains steady growth, though prices are tightly regulated.

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Financial Trajectory

1. Revenue Forecasts

Market research indicates the global inhaled corticosteroid market will grow at a compound annual growth rate (CAGR) of approximately 4.5% over the next five years [3]. Fluticasone furoate's share is expected to maintain dominance in inhaler sales, driven by a combination of patent protection and ongoing clinical investment.

Pre-pandemic estimates placed annual revenues for fluticasone furoate-containing products at approximately $2 billion globally. Post-2023, with patent expiration scenarios, revenues could decline 15-25% annually in generic markets unless companies innovate or diversify.

2. Impact of Patent Expirations

The upcoming patent expirations could lead to substantial revenue declines unless companies:

• Launch next-generation formulations
• Secure new patents via method-of-use or delivery patents
• Expand into emerging markets

Historically, similar compounds experienced a 20-30% revenue decline after generic entry (e.g., fluticasone propionate products [4]).

3. Strategic Growth Opportunities

• Combination Therapies: Pairing with long-acting beta-agonists (LABAs) like vilanterol enhances treatment efficacy. The Breo Ellipta franchise generated over $4 billion in annual sales, highlighting significant revenue potential [5].
• New Indications: Expanding into pediatric or rare respiratory conditions can open new revenue streams.
• Biologics Integration: Collaborations with biologic therapies for severe asthma could diversify the portfolio.

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Market Challenges and Risks

• Pricing Pressures: Payers increasingly favor generics, exerting downward pressure on prices.
• Regulatory Hurdles: Additional approvals require significant investment, with no guaranteed success.
• Patent Litigation: Patent disputes can delay market entry of generics.

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Outlook and Strategic Implications

The next five years will be pivotal. Companies that proactively navigate patent expirations by innovating through combination treatments, new formulations, or expanding into underserved markets will preserve revenue streams. Diversification and lifecycle management are critical in mitigating market risks.

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Key Takeaways

• Market Leadership: Fluticasone furoate maintains dominance in inhaled corticosteroid segments, driven by superior pharmacological properties and adherence benefits.
• Patent Lifecycle: Patent expiration in the coming years risks significant revenue declines; strategic patent extensions or diversification are essential.
• Growth Opportunities: Expansion through combination therapies and geographic markets, particularly Asia-Pacific, presents substantial opportunities.
• Market Challenges: Competition from generics, pricing pressures, and regulatory complexities warrant vigilant strategic planning.
• Future Outlook: Innovative formulations and indication expansion will be vital for sustained financial performance.

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FAQs

Q1. When are the patents for fluticasone furoate expected to expire?
Most primary patents are expected to expire between 2025 and 2027, opening the market to generic competitors and necessitating strategic adaptation.

Q2. How does fluticasone furoate differ from fluticasone propionate?
Fluticasone furoate has a higher receptor affinity and longer duration of action, enabling once-daily dosing, which improves patient compliance compared to fluticasone propionate.

Q3. What are the primary markets driving growth for fluticasone furoate?
North America remains dominant, with significant growth potential in Asia-Pacific and Europe, driven by rising respiratory disease prevalence and expanding healthcare infrastructure.

Q4. What strategies can companies adopt post-patent expiry?
Diversifying product offerings, developing new formulations, securing method-of-use patents, expanding geographic reach, and integrating into combination therapies are critical strategies.

Q5. What role do regulatory approvals play in the financial success of fluticasone furoate?
Regulatory approvals expand indications and markets, directly impacting revenue. Conversely, delays or restrictions can limit commercial potential and impact financial trajectories.

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References

[1] Smith, J. et al. "Pharmacokinetics and Pharmacodynamics of Fluticasone Furoate," Clinical Pharmacology, 2022.
[2] U.S. Patent Office. "Patent Expiry Dates for Fluticasone Furoate," 2023.
[3] Market Research Future. "Inhaled Corticosteroid Market Forecast," 2022.
[4] IMS Health Data. "Generic Entry Impact on Respiratory Drugs," 2021.
[5] GSK Annual Report. "Breo Ellipta Revenue and Portfolio Review," 2022.