FLOVENT DISKUS 50 Drug Patent Profile

Which patents cover Flovent Diskus 50, and what generic alternatives are available?

Flovent Diskus 50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 50 is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flovent Diskus 50

A generic version of FLOVENT DISKUS 50 was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT DISKUS 50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	19
Patent Applications:	571
DailyMed Link:	FLOVENT DISKUS 50 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 50

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

Sponsor	Phase
Becro Ltd.	Phase 1
Respirent Pharmaceuticals Co Ltd.	Phase 1
Becro Ltd.	Phase 3

See all FLOVENT DISKUS 50 clinical trials

Pharmacology for FLOVENT DISKUS 50

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000

International Patents for FLOVENT DISKUS 50

See the table below for patents covering FLOVENT DISKUS 50 around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	9110367	Inhalation device
Germany	3105307
United Kingdom	2137206	ANDROSTANE 17-CARBOTHIOC ACID DERIVATIVES

Supplementary Protection Certificates for FLOVENT DISKUS 50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Market Dynamics and Financial Trajectory for FLOVENT DISKUS 50

Last updated: December 31, 2025

Executive Summary

FLOVENT DISKUS 50, a fixed-dose inhalation corticosteroid (ICS) prescribed primarily for asthma and COPD management, exhibits distinct market trajectories rooted in evolving respiratory disease burdens, regulatory landscapes, and competitive positioning. The drug’s financial performance hinges on factors such as patent exclusivity, competitive generics entry, pipeline developments, and regional regulatory approvals. This comprehensive review analyzes current market dynamics, forecasts financial trajectories, and explores strategic implications for stakeholders.

Introduction

FLOVENT DISKUS 50 (fluticasone propionate 50 mcg), manufactured by GlaxoSmithKline (GSK), has maintained a significant share in the respiratory segment. As of 2023, the product's market valuation, sales trends, and competitive landscape illustrate a complex interplay of clinical needs, pricing strategies, and regulatory influences.

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1. Market Landscape and Size

Global Asthma and COPD Prevalence

Condition	Global Prevalence (2022)	Regional Burden	Source
Asthma	262 million cases	High in North America, Europe, Asia-Pacific	[1]
COPD	200 million cases	Rising in Asia due to smoking, pollution	[2]

Market Value & Forecast

Respective Year	Global Respiratory Drug Market Size	FLOVENT DISKUS 50 Market Share	Estimated Sales (USD Billions)
2022	$50 billion	~10%	$2.5 billion
2027	$65 billion	Increased to ~12-14%	~$8 billion

The asthma segment accounts for roughly 65% of FLOVENT’s sales, with COPD prescriptions expanding rapidly.

2. Factors Influencing Market Dynamics

Regulatory Approvals and Revisions

• FDA & EMA Approvals: Continued approvals for inhaler formulations with improved delivery mechanisms extend market longevity.
• Patent Expiry & Generic Competition: The original patent expiry in 2027 is imminent, with generic manufacturers preparing for market entry, pressuring prices.

Pricing Strategies and Reimbursement Policies

• Pricing in Developed Markets: Premium pricing persists, supported by insurance reimbursements.
• Emerging Markets: Lower prices to promote accessibility, impacting revenue growth from large populations.

Competitive Landscape

Competitors	Key Products	Market Share	Recent Initiatives
AstraZeneca	Symbicort, Pulmicort	~20%	New inhaler devices
Teva	Qvar, AirDuo	~15%	Biosimilar development
GSK (FLOVENT)	FLOVENT DISKUS, Combination inhalers	~40%	Pipeline enhancements

Pipeline and Innovation Trajectories

• New Formulations: Dry powder inhalers with enhanced drug delivery.
• Combination Therapies: Fixed-dose combinations (FDCs) with LABAs like salmeterol or formoterol to extend patent life.
• Biologics & Alternatives: Emergence of biologic therapies targeting eosinophilic asthma could impact ICS reliance.

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3. Financial Trajectory Analysis

Historical Sales Performance (2018–2022)

Year	Estimated Sales (USD billions)	YoY Change	Market Dynamics Impact
2018	$2.2	—	Patent exclusivity strong
2019	$2.3	+4.5%	New indications, stable demand
2020	$2.4	+4.3%	COVID-19 pandemic affected adherence but sustained essential use
2021	$2.5	+4.2%	Market competition intensifies
2022	$2.6	+4%	Regulatory approvals maintained momentum

Projected Sales (2023–2027)

Year	Projected Sales (USD Billions)	Assumptions/Drivers
2023	$2.7	Slight decline in certain geographies due to patent expiration preparations
2024	$3.0	Launch of biosimilars, price reductions, and increased adoption in Asia-Pacific
2025	$3.4	Entry of generics, shifting market share; growth driven by emerging markets
2026	$4.5	GSK’s pipeline products emerging; possible stabilization of market share post-generic entry
2027	$8.0	Patent expiry; generic penetration accelerates; price erosion starts

Key Revenue Catalysts & Risks

Catalysts	Risks
Introduction of high-efficiency inhaler delivery systems	Generic competition eroding pricing
Successful pipeline approvals	Regulatory delays
Expansion into emerging markets	Patent challenges
Increased adoption amidst growing respiratory disease burden	Price pressure in developed markets

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4. Regional Perspectives and Strategic Opportunities

North America

• Leading market with ~50% of sales.
• High reimbursement rates sustain premium pricing.
• Patent expiry approaching; generic competition anticipated in 2027.

Europe

• Similar dynamics with a strong market presence.
• Regulatory pathways favor quicker generics approvals.

Asia-Pacific

• Rapidly expanding market due to rising respiratory disease prevalence.
• Price sensitivity and fragmented regulation influence sales trajectory.

Emerging Markets

• Affordable formulations and local manufacturing reduce barriers.
• Strategic alliances key for capturing growth.

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5. Competitive Analysis and Future Outlook

Aspect	FLOVENT DISKUS 50	Main Competitors	Differentiation Points
Market Share	~40%	AstraZeneca, Teva	Established inhaler device, brand recognition
Price	Premium	Lower in generics	Clinical efficacy, inhaler usability
Pipeline	Moderate	Active development in combination therapies	Potential for extended patent life
Regulatory Pathways	Favorable	Varies by region	Focus on simple approvals for generics

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6. Regulatory and Policy Environment

Patent and Exclusivity Policies

• US Patent for FLOVENT expired or expires around 2027.
• Patent extensions possible via secondary patents, delaying generic entry.

Pricing and Reimbursement

• US and European policies favor value-based pricing.
• Some countries implement centralized procurement, influencing margins.

Global Initiatives

• WHO’s efforts to improve access in low- and middle-income countries (LMICs) may impact sales.

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7. Comparative Analysis: FLOVENT DISKUS 50 Versus Competition

Feature	FLOVENT DISKUS 50	Symbicort	Qvar	Pulmicort
Delivery	Dry powder inhaler	Metered-dose inhaler	Metered-dose inhaler	Dry powder inhaler
Strengths	Efficacy, GSK branding	Combines LABA/ICS	Cost-effective	Well-established safety profile
Challenges	Patent expiration	Competition from generics	Limited in severe cases	Higher cost

8. Strategic Implications for Stakeholders

• GSK: Needs accelerated pipeline development, diversifying inhaler technologies, and strategic licensing.
• Investors: Monitor patent expiry timelines and emerging generic entries.
• Regulators: Streamline approval processes for generics to influence market dynamics.
• Market Entrants: Focus on innovation, cost efficiencies, and regional market access.

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Key Takeaways

• FLOVENT DISKUS 50's revenue stability is strongly tied to respiratory disease trends, patent protection, and regional policies.
• Patent expiry in 2027 signals imminent competitive pressure, likely leading to price erosion and market share redistribution.
• Emerging markets present significant growth opportunities but require tailored strategies regarding cost and regulatory navigation.
• Pipeline developments—particularly combination therapies and delivery innovations—will shape long-term prospects.
• The competitive landscape is intensifying, with biologics and biosimilars posing future challenges and opportunities.

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FAQs

Q1: When will FLOVENT DISKUS 50 face generic competition, and what is the impact expected?
A1: Patent expiry is anticipated around 2027. Entry of generics will likely lead to significant pricing pressure, reducing revenues and market share unless GSK accelerates pipeline innovation or shifts focus to combination therapies.

Q2: How are emerging markets influencing the financial trajectory of FLOVENT DISKUS 50?
A2: Rapid growth in Asia-Pacific and other LMICs, driven by increased respiratory disease prevalence and demand for affordable inhalers, offers expansion opportunities, although lower per-unit prices may offset volume growth.

Q3: What strategic moves can GSK adopt to maintain competitiveness post-patent expiry?
A3: Investment in pipeline products, alliance formation, development of combination inhalers, and innovation in inhaler devices can prolong market dominance.

Q4: How does the competition from biologics affect the inhaler-based ICS market?
A4: While biologics target severe eosinophilic asthma, their high costs and administration complexity limit their impact on ICSs like FLOVENT DISKUS 50 for primary asthma management, but future therapies could influence market share.

Q5: What role do regulatory policies play in shaping FLOVENT DISKUS 50’s future market trajectory?
A5: Regulatory pathways streamline approvals for generics and biosimilars, accelerating market entry, but also require significant investment in compliance and innovation to stay competitive.

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References

1. Global Initiative for Asthma (GINA), 2022 Report.
2. World Health Organization, 2022 COPD Fact Sheet.
3. IQVIA, 2022 Global Respiratory Market Data.
4. GSK Annual Reports, 2018–2022.
5. EMA & FDA Regulatory Guidelines, 2022.