FLONASE Drug Patent Profile

When do Flonase patents expire, and when can generic versions of Flonase launch?

Flonase is a drug marketed by Haleon Us Holdings and is included in three NDAs. There are three patents protecting this drug.

The generic ingredient in FLONASE is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Flonase

Annual sales in 2022 were $2mm indicating the motivation for generic entry (peak sales were $1.1bn in 2005).

Indicators of Generic Entry

Summary for FLONASE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	24
Patent Applications:	571
Drug Prices:	Drug price information for FLONASE
Drug Sales Revenues:	Drug sales revenues for FLONASE
What excipients (inactive ingredients) are in FLONASE?	FLONASE excipients list
DailyMed Link:	FLONASE at DailyMed

See drug prices for FLONASE

See drug sales revenues for FLONASE

Recent Clinical Trials for FLONASE

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
University of South Florida	Phase 3
St. Paul's Sinus Centre	Phase 4

See all FLONASE clinical trials

US Patents and Regulatory Information for FLONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994		DISCN	Yes	No
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED;NASAL	205434-001	Jul 23, 2014		OTC	Yes	No
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y

Expired US Patents for FLONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994

International Patents for FLONASE

See the table below for patents covering FLONASE around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8100976
Spain	499394
Ireland	862287
Spain	8600936
Ireland	810282
Ireland	51395	STEROIDS OF THE ANDROSTANE SERIES

Supplementary Protection Certificates for FLONASE

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
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND 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
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
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

Market Dynamics and Financial Trajectory for Flonase (Fluticasone Propionate)

Last updated: December 9, 2025

Executive Summary

Flonase, a leading intranasal corticosteroid (INCS), is widely prescribed for allergic rhinitis and nasal congestion. This analysis provides a comprehensive overview of its current market landscape, growth drivers, competitive positioning, revenue trajectories, and future outlook. The global Flonase market is influenced by regulatory policies, evolving consumer preferences, and biosimilar entry points, shaping a nuanced competitive environment. Revenue projections suggest sustained growth fueled by increasing allergy prevalence, expanding indications, and product innovation. Analyzing these factors reveals key strategic considerations for stakeholders in the pharmaceutical landscape.

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Introduction

Flonase (fluticasone propionate), developed by GlaxoSmithKline (GSK), has been a mainstay in allergy treatment since its introduction in the early 2000s. The medication's unique delivery mechanism and efficacy have cemented its market position. Understanding Flonase's market dynamics involves analyzing epidemiological trends, regulatory factors, competitive landscape, and financial performance metrics. These elements directly influence its growth potential and strategic positioning in the broader pharmaceutical ecosystem.

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1. Current Market Landscape of Flonase

Global Market Size and Revenue (2022–2023)

Region	Market Size (USD Billion)	CAGR (2018-2023)	Key Drivers
North America	3.2	4.2%	High allergy prevalence, established healthcare infrastructure
Europe	1.4	3.8%	Aging population, OTC availability
Asia-Pacific	0.9	8.5%	Growing awareness, increasing allergy cases
Rest of World	0.4	4.0%	Emerging markets, stricter regulatory controls

Source: Market Research Future (MRFR), 2023.

Market Segmentation by Application

Application	Market Share (%)	Key Trends
Allergic Rhinitis	65%	Dominant indication, expanding into pediatrics
Non-Allergic Rhinitis	15%	Growing but limited adoption
Nasal Polyps	12%	Emerging indication with recent approvals
Other (e.g., sinusitis)	8%	Niche markets

Distribution Channels

Channel	Market Share (%)	Notable Features
Prescription (Rx)	65%	Dominant, but declining due to OTC expansion
Over-the-Counter (OTC)	35%	Increasing availability, consumer-driven growth

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2. Market Drivers and Restraints

Key Drivers

• Growing Prevalence of Allergic Rhinitis: The World Allergy Organization estimates that over 400 million people suffer from allergic rhinitis globally, fueling demand for safe and effective intranasal therapies [1].
• Product Expansion and Indications: Recent approvals for nasal polyps and non-allergic rhinitis increase contraindications and patient segments.
• OTC Availability: Transition from prescription to OTC sales broadens consumer access and boosts volume.
• Preference for Non-Systemic Therapies: Patients and physicians favor topical corticosteroids over systemic medications due to reduced side effects.
• Innovations in Delivery Systems: Advances in nasal spray devices improve compliance and efficacy, encouraging sustained demand.

Market Restraints

• Competitive Market Entry: Biosimilars and generics, such as Mometasone and other corticosteroids, threaten market share.
• Regulatory Hurdles: Stringent approval pathways and safety regulations can delay new formulations.
• Price Sensitivity: Community healthcare settings emphasize cost-effectiveness, impacting premium pricing strategies.
• Consumer Preference for OTC: Increased OTC sales reduce prescription revenue but inherently expand market size.

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3. Competitive Landscape and Key Players

Company	Product Portfolio	Market Share (%)	Strategy Highlights
GlaxoSmithKline (GSK)	Flonase, Flonase Sensimist	55%	Wide distribution network, product innovation
Teva Pharmaceuticals	Generic corticosteroids	15%	Price competition, biosimilar pipeline
Perrigo	OTC formulations	10%	Over-the-counter expansion, aggressive marketing
Other Players	Various local brands	20%	Market fragmentation

Note: GSK remains the dominant player, with Flonase holding the majority share in prescription nasal steroids.

Biosimilar and Generic Entry

Pending biosimilar approvals, competition is expected to intensify. The U.S. FDA has granted tentative approvals for generic Fluticasone formulations, which could reduce pricing power and compress margins over the next 3-5 years.

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4. Financial Performance and Trajectory

Historical Revenue and Profitability (2018–2022)

Year	Revenue (USD Billion)	YoY Growth (%)	Operating Margin (%)	Notes
2018	2.2	N/A	35%	Established mainstream product
2019	2.4	9.1%	36%	Regulatory approvals for new formulations
2020	2.6	8.3%	37%	COVID-19 impact limited
2021	2.9	11.5%	38%	OTC expansion gains momentum
2022	3.2	10.3%	39%	Increased vaccination coverage aids allergy diagnosis

Projected Revenue Outlook (2023–2028)

Year	Estimated Revenue (USD Billion)	CAGR (%)	Assumptions
2023	3.4	6.3%	Continued OTC growth, new indications
2024	3.6	5.9%	Biosimilar threats commence, moderate price pressures
2025	3.9	8.3%	Expansion into emerging markets
2026	4.3	10%	Product innovation, increased awareness
2027	4.6	7%	Regulatory stabilizations, patent expiries managed
2028	5.0	8.7%	Market maturity, diversified indications

Source: Market forecasts by IQVIA, 2023; projections assume moderate biosimilar penetration and ongoing consumer demand.

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5. Regulatory and Policy Factors Impacting Market Trajectory

• FDA & EMA Approvals: Regular updates to safety profiles and new indication approvals drive product lifecycle extension.
• OTC Regulation: Transition from Rx to OTC (e.g., Flonase Sensimist in 2020) broadens market access.
• Price Regulation Policies: Government-led initiatives targeting inhalers and nasal sprays impacting pricing strategies.
• Biosimilar Regulations: Approval pathways could accelerate generic entry, affecting revenue streams.

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6. Future Trends and Opportunities

Trend	Impact	Strategic Recommendations
Digital Health Integration	Improved patient adherence, data collection	Invest in digital platforms for customer engagement
Biosimilar and Generic Competition	Price pressures, margin compression	Focus on differentiation, patent strategy
Personalized Medicine Approaches	Tailored therapy, new formulation development	Partnering with biotech firms, R&D investments
Expansion in Emerging Markets	Untapped consumer base	Local partnerships, pricing strategies
Product Line Diversification	Broadened indications, lifecycle extension	Breeding new formulations, combination therapies

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7. Comparative Analysis: Flonase vs. Market Peers

Aspect	Flonase (GSK)	Mometasone (Allergan/Teva)	Nasacort (TYLENOL)	Rhinocort (AstraZeneca)
Market Share (%)	55	15	15	10
Main Indication	Allergic rhinitis	Allergic rhinitis	Allergic rhinitis	Allergic rhinitis
Delivery System	Nasal spray	Nasal spray	Nasal spray	Nasal spray
OTC Availability	Yes	Yes	Yes	Yes
Revenue (2022)	USD 3.2 bn	USD 0.9 bn	USD 0.4 bn	USD 0.5 bn

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8. Strategic Insights and Risks

Opportunities

• Expanding indications (nasal polyps, chronic sinusitis)
• Leveraging OTC expansion for broader consumer reach
• Digital health integration for adherence and data collection
• Entering emerging markets with tailored strategies

Risks

• Biosimilar and generic competition reducing pricing power
• Regulatory delays impacting pipeline
• Pricing pressures driven by healthcare reforms
• Consumer safety concerns impacting formulations

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Key Takeaways

• Robust Market Position: GSK’s Flonase commands a dominant market share via extensive distribution and multiple indications.
• Growth Prospects: The forecast CAGR of ~8% from 2023-2028 reflects evolving indications, OTC availability, and market expansion, especially in Asia-Pacific and emerging economies.
• Competitive Landscape: Biosimilars and generics pose significant threats, emphasizing the need for continuous innovation and patent strategy.
• Revenue Drivers: Increasing allergy prevalence, product innovation, and regulatory approvals are central to sustained growth.
• Strategic Focus: Market leaders should emphasize differentiations through formulations, digital health integration, and regional expansion to maintain competitiveness.

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FAQs

1. What factors are driving the global growth of Flonase?

The primary factors include rising allergy prevalence, expanding indications such as nasal polyps, OTC availability, increasing consumer awareness, and product innovations in delivery mechanisms.

2. How will biosimilar competition impact Flonase’s market share?

Biosimilars and generics are expected to exert downward pressure on prices and margins. Strategic patent protections and innovation are vital to offset competitive threats.

3. What are key regional opportunities for Flonase expansion?

Emerging markets in Asia-Pacific and Latin America offer growth potential due to rising allergy awareness, expanding healthcare infrastructure, and increasing OTC sales.

4. How has OTC expansion affected Flonase’s revenue?

OTC availability has increased consumer access, resulting in higher volume sales and brand recognition. However, it may reduce revenue from prescription channels but overall expands the market size.

5. What are future product innovation trends for intranasal corticosteroids?

Innovations include bioavailability enhancements, combination therapies, targeted delivery systems, and digital adherence solutions to improve efficacy and patient experience.

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References

[1] World Allergy Organization. "Allergy Prevalence Data," 2021.