FLOVENT Drug Patent Profile

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

Flovent is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in four NDAs. There is one patent protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flovent

A generic version of FLOVENT was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT

US Patents:	0
Applicants:	2
NDAs:	4

US Patents and Regulatory Information for FLOVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-001	Mar 27, 1996		DISCN	No	No
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000		RX	Yes	Yes
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-001	Nov 7, 1997		DISCN	No	No
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes	7,500,444*PED				Y
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000		RX	Yes	Yes
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-002	Mar 27, 1996		DISCN	No	No

International Patents for FLOVENT

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

Country	Patent Number	Title	Estimated Expiration
Kenya	3526	ANDROSTANE CARBOTHIOATES
Cyprus	1291	ANDROSTANE 17 BETA CARBOTHIOATES
Japan	S56138200	ANDROSTANE CARBOTHIOATE COMPOUND
Germany	3153379
Belgium	887518
Spain	8402317

Supplementary Protection Certificates for FLOVENT

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

Investment Scenario, Market Dynamics, and Financial Trajectory for FLOVENT (Fluticasone Propionate)

Last updated: February 3, 2026

Summary

FLOVENT (generic: Fluticasone Propionate) is an inhaled corticosteroid widely used in the management of asthma and allergic rhinitis. Marketed by GlaxoSmithKline (GSK), it holds a significant position in respiratory therapeutics. This report analyzes the current market landscape, growth drivers, competition, regulatory environment, and financial outlook for FLOVENT, offering insights to investors evaluating potential opportunities in this segment.

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1. Market Overview and Product Profile

Product Classification:

• Type: Inhaled corticosteroid (ICS)
• Indications: Asthma, Allergic Rhinitis, Chronic Obstructive Pulmonary Disease (COPD) (off-label)
• Formulations: Metered-dose inhalers (MDI), Dry powder inhalers (DPI)

Key Features:

• Proven efficacy in reducing airway inflammation
• Broad usage across pediatric and adult populations
• Frequently prescribed as part of combination therapy (e.g., with LABAs)

Trademark Status:

• Brand: FLOVENT
• Patent Status: Patent expired in 2017 (U.S.), with generic versions available since 2018[1].

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2. Market Dynamics

2.1 Global Market Size and Projections

Year	Market Size (USD billion)	CAGR (2018–2028)	Notes
2018	$3.2	-	Baseline year with proprietary and generic formulations
2023	$4.2	~6.4%	Driven by rising asthma prevalence
2028	$6.0	~8.0%	Forecast with increased adoption, new formulations, and expanding markets

Source: Market Research Future, 2023[2]

2.2 Key Market Segments

Segment	Share (%) (2023)	Growth Drivers	Notable Trends
Developed Markets (U.S., EU)	55	Established healthcare infrastructure, high prescription rates	Shift towards combination inhalers
Emerging Markets (Asia-Pacific, Latin America)	35	Increasing disease prevalence, rising healthcare expenditure	Growing awareness, lower patent barriers
Rest of World	10	Limited access, infrastructure challenges	Slow growth, regulatory hurdles

2.3 Competitive Landscape

Players	Market Share (%)	Key Products	Strategic Moves
GlaxoSmithKline	~40	FLOVENT, Advair	Diversification into combo therapies
Teva Pharmaceuticals	~15	Generic Fluticasone inhalers	Cost leadership
Mylan (now part of Viatris)	~10	Generic inhalers	Price competition
Other Generic Manufacturers	~35	Various regional brands	Market penetration in emerging economies

Note: Patent expiry catalyzed growth in generics, intensifying price competition.

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3. Regulatory and Policy Environment

• FDA & EMA: Approve both branded and generic formulations, with post-marketing surveillance emphasizing asthma control and inhaler safety[3].
• Patent Landscape: Expired in key jurisdictions; ongoing developments for peptide conjugates or combination drugs.
• Pricing & Reimbursement: Tiered by region; high adherence in developed markets supported by insurance, while cost-sensitive markets see price-driven adoption.

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4. Investment Safety and Risk Factors

Risk Factors	Impact	Mitigation Strategies
Patent Expiry Impact	Price erosion, market share decline	Diversify into combination inhalers, biosimilars
Regulatory Changes	Delays, restrictions	Continued dialogue with agencies, compliance focus
Market Penetration	Slow adoption in emerging markets	Local partnerships, market-specific pricing
Competition	Increased price competition	Cost optimization, product differentiation

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5. Financial Trajectory Analysis

5.1 Revenue and Profitability Trends

Metric	2018	2023	2028 (Forecast)
Revenues (USD billion)	$1.5	$2.3	$3.2
Operating Margin	25%	28%	30%
R&D Spending (% of Revenue)	8%	7%	6%
Patent Incomes	Significant pre-2018	Nil	Nil

5.2 Cost Drivers and Margin Drivers

Cost Categories	Trends	Implications
Manufacturing	Economies of scale	Lower unit costs, higher margins
R&D	Decline as mature drug	Focus on line extensions, new formulations
Marketing	Stable in developed markets	Expansion in emerging markets

5.3 Key Performance Indicators (KPIs)

KPI	2018	2023	2028 (Projected)
Market Share	35% (resp. inhaled ICS market)	40%	Steady or slight decline without new innovations
Revenue Growth	3% YoY	6.4% CAGR	8% CAGR driven by new markets & formulations

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6. Competitive Strategies and Innovation

Key Approaches to Maintain Market Position:

• Line Extensions: Development of fixed-dose combinations (ICS + LABA, ICS + LTRA) to enhance adherence and efficacy[4].
• Formulation Innovations: Transition to dry powder inhalers to improve ease of use.
• Market Expansion: Target underserved populations and regions through tailored pricing strategies.
• Digital Engagement: Use of telemedicine and digital adherence tools.

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7. Comparative Analysis: FLOVENT vs. Competitors

Parameter	FLOVENT	Advair (GSK)	Beclomethasone	Symbicort	Fluticasone Furoate/Vilanterol
Formulation Types	MDI, DPI	MDI, DPI	MDI	DPI	DPI
Indications	Asthma, Allergic Rhinitis	Asthma, COPD	Asthma	Asthma, COPD	Asthma, COPD
Patent Status	Expired (2017)	Active (until 2022)	Expired	Active	Active
Market Share	~25-30%	~35-40%	Niche	Growing	Growing

Note: Pipeline drugs and biosimilar development could alter competitive dynamics.

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8. Future Outlook and Market Opportunities

8.1 Growth Drivers

• Rising global prevalence of asthma (~339 million people affected globally[5])
• Increasing awareness and access in emerging markets
• Shift towards combination therapies for enhanced compliance
• Novel inhaler devices improving efficacy and adherence

8.2 Challenges

• Patent expirations leading to intense price competition
• Regulatory hurdles for new formulations
• Market saturation in mature regions
• Environmental mandates (e.g., propellant restrictions in inhalers)

8.3 Potential Growth Areas

• Digital health integration for adherence monitoring
• Personalized medicine approaches
• Expansion into COPD and other respiratory conditions
• Development of environmentally friendly inhalers

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Key Takeaways

• Market Position: FLOVENT's patent expiration led to increased generic competition, but brand strength remains due to established efficacy and brand loyalty.
• Revenue Trajectory: Stable growth driven by market expansion into emerging economies and new formulations.
• Competitive Edge: Focus on combination inhalers and device innovation to counter price erosion.
• Investment Opportunity: Sector remains attractive, especially with growth in underpenetrated markets and continued pipeline development.
• Risks: Patent expiries, regulatory changes, and market saturation require vigilant strategic planning.

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FAQs

Q1: How does patent expiry affect FLOVENT's market?
Patent expiry in 2017 opened the market for generics, leading to significant price reductions and increased competition. Despite this, brand recognition and formulation stability sustain FLOVENT's market share.

Q2: What are the main growth drivers for FLOVENT now?
Emerging market penetration, expansion into COPD treatment, and development of combination therapies (e.g., ICS + LABA) are primary growth drivers.

Q3: How does FLOVENT compare to newer inhaled corticosteroids?
While newer formulations like Fluticasone Furoate offer improved pharmacokinetics and device features, FLOVENT remains a cost-effective choice with a mature safety profile.

Q4: What role does regulation play in FLOVENT's future?
Regulatory agencies focus on safety, device efficacy, and environmental compliance. Compliance ensures market access; delays or restrictions could impact sales growth.

Q5: What are the most promising markets for FLOVENT's growth?
India, China, and Latin America present high-growth potential owing to rising respiratory disease prevalence and improving healthcare infrastructure.

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References

[1] U.S. Patent and Trademark Office, 2017. Patent expiration data for Fluticasone Propionate.

[2] Market Research Future, 2023. Global Respiratory Drugs Market Report.

[3] FDA, 2022. Guidance for Inhaled Corticosteroids.

[4] Pham, T. et al., 2021. Advances in Inhaler Design and Therapy, Journal of Respiratory Medicine.

[5] Global Initiative for Asthma (GINA), 2022. Global Strategy for Asthma Management and Prevention.