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 eleven 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:	11
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	162
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:

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
University of Alabama at Birmingham	PHASE2
Thammasat University	PHASE4

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	11,090,294
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	8,511,304*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

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	9,320,862
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018	7,101,866
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	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
Australia	2003253367	A FLUID DISPENSING DEVICE
United Kingdom	0325629
China	101528357	A fluid dispensing device

Supplementary Protection Certificates for FLUTICASONE FUROATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Market Dynamics and Financial Trajectory for Fluticasone Furoate

Last updated: February 26, 2026

Fluticasone furoate (FF) is a corticosteroid used in inhaler therapies for asthma and allergic rhinitis. Its market landscape is shaped by product approvals, competitive positioning, and emerging indications.

Product Overview and Approvals

• Indications: Asthma (maintenance) and allergic rhinitis.
• Formulations:
  • Intranasal spray ("Veramyst" and "Avamys").
  • Inhaler ("Arnuity Ellipta" in the US; marketed by GSK).
• Regulatory status:
  • Approved in the US (by FDA) and Europe (by EMA) for allergic rhinitis.
  • Approved in the US for asthma management as an inhaler since 2014.
  • Regulatory pathways favor fast approval due to established corticosteroid class.

Market Size and Growth Drivers

• Global asthma therapy market: Valued at approximately USD 13 billion in 2022, projected to reach USD 16 billion by 2027, growing at a CAGR of 4.5%.[1]
• Allergic rhinitis market: Estimated at USD 4.2 billion in 2022, expected to grow at 3.8% CAGR through 2027.[2]

Key Drivers

• Increasing prevalence of asthma and allergic rhinitis.
  • WHO reports asthma affects over 262 million globally, with rising incidence in urban areas.[3]
• Expanding use of inhaled corticosteroids (ICS) as first-line therapy.
• Generic and biosimilar erosion reducing branded sales.
• New formulation improvements to enhance adherence and efficacy.

Competitive Landscape

Competitor	Product(s)	Market Share (%)	Key Differentiator
GlaxoSmithKline	Arnuity Ellipta, Flonase (fluticasone propionate)	~40% in US asthma inhaler market	Established portfolio, high efficacy
AstraZeneca	Symbicort, Nasacort	~25% combined	Dual therapy option
Teva	Qnasl	niche presence	Nasal spray formulations

Fluticasone furoate competes with fluticasone propionate and other ICS formulations.

Revenue and Financial Trends

GSK and Partner Segment Data

GSK markets Arnuity Ellipta and Nasal sprays with combined revenues of approximately USD 2.2 billion in 2022.[4]

• Arnuity Ellipta:
  • US sales: USD 800 million (2022) — growth driven by expanded indications and formulary inclusion.
  • Europe and emerging markets contribute USD 400 million.
• Nasal formulations:
  • Total sales: USD 1.4 billion globally.

Revenue Visibility and Risks

• New product launches and formulations could enhance revenue.
• Patent expiries of key formulations in 2024-2027 threaten revenue erosion.
• Competition from biosimilars and generics poses significant margin pressure.

Future Financial Trajectory and Market Factors

• Growth projections:
  • GSK forecasts 4-6% annual growth in respiratory therapies through 2026.
• Innovations:
  • Fixed-dose combinations targeting asthma and COPD.
  • Extended-release formulations improving adherence.
• Regulatory initiatives:
  • Increasing approval of nasal sprays in emerging markets.
  • US FDA priority review for potential new indications.

Price and Market Penetration Policies

• Market access expands through formulary placement.
• Price inflation targeted at USD 25-35 per inhaler device.
• Competitive pricing pressures in developed markets limit margins.

Risks and Opportunities

• Risks:
  • Market saturation in mature regions.
  • Patent cliffs for key formulations.
  • Regulatory delays for pipeline candidates.
• Opportunities:
  • Growing asthma and allergic rhinitis prevalence.
  • Expansion into emerging markets.
  • Development of combination therapies with other anti-inflammatory drugs.

Key Takeaways

Fluticasone furoate maintains a stable market position driven by its efficacy in asthma and allergic rhinitis. Revenue growth depends on expanding indications, formulation improvements, and geographic expansion. Patent expiries and intensifying competition pose risks to market share and margins. The outlook remains cautiously optimistic, with potential for moderate growth aligned with respiratory disease trends.

FAQs

1. How does fluticasone furoate differ from fluticasone propionate?
FF has higher receptor affinity and longer lung retention, allowing once-daily dosing, compared to twice-daily doses typically required for fluticasone propionate.

2. What are key patent expiry dates for fluticasone furoate formulations?
In the US, the primary patents covering Arnuity Ellipta expire in 2024-2027, opening opportunities for generics.

3. Which markets offer the most growth potential for FF?
Emerging markets such as China, Brazil, and India present increasing asthma and allergic rhinitis prevalence and expanding healthcare access.

4. What are the main competitors to fluticasone furoate-containing products?
Products containing mometasone, budesonide, and beclomethasone compete directly, with similarities in efficacy and pricing.

5. How might pipeline developments influence the financial outlook?
Pipeline candidates combining FF with other anti-inflammatory drugs and new nasal delivery systems could boost future revenues if approved.

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References

1. GlobalData. (2022). Market size and forecast for asthma treatments.
2. MarketsandMarkets. (2022). Allergic rhinitis therapeutics industry analysis.
3. World Health Organization. (2018). The Global Asthma Report.
4. GSK. (2023). Annual Report.