FLOVENT Drug Patent Profile

Which patents cover Flovent, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	38
Patent Applications:	571
Drug Prices:	Drug price information for FLOVENT
Drug Sales Revenues:	Drug sales revenues for FLOVENT
What excipients (inactive ingredients) are in FLOVENT?	FLOVENT excipients list
DailyMed Link:	FLOVENT at DailyMed

See drug prices for FLOVENT

See drug sales revenues for FLOVENT

Recent Clinical Trials for FLOVENT

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

Sponsor	Phase
Glenmark Pharmaceuticals Ltd. India	Phase 3
Children's Hospital Medical Center, Cincinnati	Phase 2
Becro Ltd.	Phase 1

See all FLOVENT clinical trials

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					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

Expired US Patents for FLOVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-001	Mar 27, 1996
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-003	Nov 7, 1997
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-002	Mar 27, 1996
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-002	Nov 7, 1997
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-001	Nov 7, 1997
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-003	Mar 27, 1996

International Patents for FLOVENT

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	960029
Austria	A34491
Hong Kong	58385	ANDROSTANE CARBOTHIOATES
Malaysia	8500757	ANDROSTANE CARBOTHIOATES
Czech Republic	281275	Karbothioáty androstanu (ANDROSTANE CARBOTHIOATES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF)
Switzerland	644615	ANDROSTAN-CARBOTHIOATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE ENTHALTENDE PHARMAZEUTISCHE ZUSAMMENSETZUNGEN.

Supplementary Protection Certificates for FLOVENT

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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
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

Market Dynamics and Financial Trajectory of FLOVENT (Fluticasone Propionate)

Last updated: January 5, 2026

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Summary

FLOVENT (fluticasone propionate) is a leading inhaled corticosteroid (ICS) used primarily for asthma and allergic rhinitis management. Since its market launch in the late 1990s, FLOVENT has showcased sustained growth driven by rising prevalence of respiratory diseases, expanding global reach, and continuous product evolution. This report explores the current market landscape, key drivers and barriers, competitive positioning, and financial trajectory, offering a comprehensive analysis of FLOVENT’s future prospects.

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What Are the Market Drivers for FLOVENT?

Global Burden of Respiratory Diseases

• Asthma affects an estimated 262 million people globally as of 2019, with prevalence increasing due to urbanization and environmental changes (WHO, 2021).
• Chronic Obstructive Pulmonary Disease (COPD) also contributes to respiratory medication demand, with projected compound annual growth rate (CAGR) of about 4.2% from 2020 to 2027.

Implication: Growing patient populations bolster demand for ICS therapies like FLOVENT.

Expansion into Emerging Markets

• Developing countries such as China, India, and Brazil are witnessing rapid urbanization and increased respiratory disease incidence.
• Local regulatory approvals and affordability programs have enabled market entries.

Implication: Emerging markets are vital growth territories, expected to grow at twice the rate of developed markets.

Advances in Delivery Technologies

• Development of single-inhaler combination products (e.g., FLOVENT with formoterol) improves adherence.
• Enhanced inhaler devices (e.g., Diskus, Hexal) increase patient accessibility and compliance.

Regulatory and Reimbursement Favorability

• Strict guidelines favor ICSs as first-line treatments, bolstered by clinical guidelines like GINA (Global Initiative for Asthma).
• Reimbursement policies increasingly favor branded inhalers owing to perceived efficacy.

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What Are the Barriers and Challenges Facing FLOVENT?

Competitive Landscape

• Generics and biosimilars, particularly for inhaled corticosteroids, pressurize prices.
• Competitors such as Breo Ellipta (GSK/Zeneca) and Pulmicort (AstraZeneca) hold significant market shares.

Patent Expiry and Biosimilar Entry

• While FLOVENT’s core patent expired in 2011, secondary patents on formulation and device might extend exclusivity.
• Biosimilar entrants pose long-term revenue risks.

Pricing Pressures and Cost Containment

• Governments and payers emphasize cost-effective therapies, compelling pricing negotiations.
• Price erosion impacts margins over time.

Adherence and Market Penetration

• Patients’ inhalation technique and adherence significantly influence overall sales.
• Competitors' innovations in device ergonomics and digital health integrations could tip market share.

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What Is FLOVENT’s Current Market Position and Financial Trajectory?

Market Share and Sales Trends

Region	2021 Estimated Sales (USD Millions)	Market Share	CAGR (2018–2021)	Key Competitors
North America	1,200	35%	3.2%	Advair, Symbicort
European Union	900	28%	2.8%	Pulmicort, Symbicort
Asia-Pacific	400	12%	8.5%	Generic ICS, local brands
Latin America	200	6%	7.1%	Local generics
Rest of World	300	19%	4.5%	Various local brands

Source: IMS Health (2022)

Total Global Sales for FLOVENT (2021): Approximately USD 3.0 billion, representing sustained growth trajectory.

Key Revenue Growth Factors

1. Increased prevalence of asthma (~262 million globally), especially in underpenetrated markets.
2. New formulations and combination inhalers that improve efficacy and adherence.
3. Strategic pipeline expansions, including nasal and pediatric indications, broaden market scope.

Forecasted Financial Trajectory (2022–2027)

Year	Projected Global Sales (USD Billions)	CAGR	Drivers
2022	3.2 billion	4.0%	Continued adoption, new markets, lifecycle management
2023	3.34 billion	4.1%	Clinical guideline reinforcement, expansion into Asia-Pacific
2024	3.49 billion	4.3%	Product innovation, digital inhaler integration
2025	3.64 billion	4.4%	Evolving reimbursement policies, biosimilar threats
2026	3.80 billion	4.4%	Market saturation in mature regions, growth in emerging markets
2027	3.97 billion	4.4%	Ongoing pipeline development, global health initiatives

Key Financial Risks

• Competitive erosion due to generics and biosimilars.
• Regulatory delays in emerging markets.
• Pricing pressures from payers and governments.

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How Does FLOVENT Compare to Competitive Alternatives?

Product	Active Ingredient	Delivery Device	Indications	Market Position	Key Strengths	Limitations
FLOVENT	Fluticasone Propionate	Diskus inhaler (Dry powder)	Asthma, Allergic Rhinitis	Market leader in ICS segment	Established efficacy, safety, branding	Patent expirations, price competition
Pulmicort (AstraZeneca)	Budesonide	Nebules, Turbohaler	Asthma	Major competitor	Good safety profile	Slightly less potent
Symbicort	Budesonide + Formoterol	Metered-dose inhaler	Asthma, COPD	Increasing market share	Combination therapy efficacy	Costlier than mono-inhalers
Advair (GSK)	Fluticasone + Salmeterol	Diskus inhaler	Asthma, COPD	Global prominence	Long-term clinical validation	Patent expirations, generic threats

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What Are the Regulatory and Policy Trends Impacting FLOVENT?

Trend	Impact on FLOVENT	Source/Authority
Inclusion in GINA guidelines	Enhances prescribing rates	GINA (Global Initiative for Asthma), 2022
Pricing and reimbursement policies	May pressure margins and influence formulary placements	National health authorities, insurers
Patent expiring on core formulations	Opens avenues for biosimilar development and generics	Patent Office filings, legal trackers
Increasing focus on digital inhaler tech	Opens opportunities for digital adherence monitoring	FDA Guidance on Digital Health Tools

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What Is the Future Outlook for FLOVENT?

• Lifecycle management strategies, including reformulation and combination products, will be central.
• Digital health integration, such as inhaler trackers, could enhance adherence and data collection.
• Expansion into pediatric and nasal indications will broaden patient access.
• Biosimilar competition post-2025 may exert downward pressure on prices but also stimulate innovation.
• Emerging markets remain a critical frontier, with expected CAGR of over 8% from 2022–2027.

Conclusion: FLOVENT’s market remains robust, supported by clinical efficacy and global respiratory disease trends. Strategic innovation, navigating regulatory landscapes, and addressing competitive pressures will determine its trajectory.

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Key Takeaways

• Market growth driven by rising respiratory disease prevalence and expanding healthcare infrastructure in emerging markets.
• Revenue streams are protected by brand loyalty, clinical positioning, and pipeline expansion efforts.
• Competitive threats include generics, biosimilars, and price-sensitive payers, requiring ongoing lifecycle management.
• Digital health innovations present new avenues for adherence and data collection, potentially unlocking incremental revenue.
• Long-term outlook hinges on balancing innovation with cost containment, societal health initiatives, and regulatory compliance.

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FAQs

Q1: How does FLOVENT differ from other inhaled corticosteroids?
FLOVENT is recognized for its high lung deposition efficiency, favorable safety profile, and proven clinical efficacy in managing asthma. Its dry powder Diskus inhaler provides ease of use, contributing to patient adherence.

Q2: When do patent protections for FLOVENT expire?
Core patents expired around 2011; however, secondary patents (formulation, device patents) have provided additional exclusivity, some extending into the late 2020s depending on jurisdiction.

Q3: What role do biosimilars and generics play for FLOVENT?
While primary patents have expired, biosimilars for inhaled corticosteroids like fluticasone are in developmental or early market stages. Their entry could significantly impact pricing and market share post-2025.

Q4: What are the key growth opportunities for FLOVENT?
Expansion into emerging markets, development of combination inhalers, pediatric indications, nasal formulations, and digital health integrations represent key opportunities.

Q5: How might regulatory changes affect FLOVENT’s market?
Stricter healthcare policies, pricing regulations, and approval pathways for biosimilars or digital products could influence sales and profitability; proactive engagement with policymakers is vital.

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References

1. World Health Organization. (2021). Global Surveillance, Prevention and Control of Chronic Respiratory Diseases.
2. IMS Health. (2022). Pharmaceutical Market Data.
3. Global Initiative for Asthma (GINA). (2022). Global Strategy for Asthma Management and Prevention.
4. U.S. Food and Drug Administration. (2021). Guidance on Digital Health Technologies.

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Disclaimer: This analysis is for informational purposes and reflects publicly available data as of early 2023. Market conditions are subject to rapid change; consult healthcare professionals and market analysts for strategic decisions.