FLOVENT DISKUS 100 Drug Patent Profile

When do Flovent Diskus 100 patents expire, and what generic alternatives are available?

Flovent Diskus 100 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 100 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 Diskus 100

A generic version of FLOVENT DISKUS 100 was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT DISKUS 100

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 100 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 100

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 100 clinical trials

Pharmacology for FLOVENT DISKUS 100

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 100

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 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000

International Patents for FLOVENT DISKUS 100

See the table below for patents covering FLOVENT DISKUS 100 around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	289264
Cyprus	2010	Inhalation device
Yugoslavia	36791

Supplementary Protection Certificates for FLOVENT DISKUS 100

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 FLOVENT DISKUS 100

Last updated: January 5, 2026

Executive Summary

FLOVENT DISKUS 100 (fluticasone propionate), an inhaled corticosteroid used predominantly for managing asthma and COPD, exhibits a complex market landscape driven by evolving treatment guidelines, patent status, competitive dynamics, regulatory environment, and healthcare policy shifts. This analysis dissects the current market conditions, provides forecasted financial trajectories, and evaluates factors influencing its long-term commercial prospects.

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Introduction

FLOVENT DISKUS 100, developed by GlaxoSmithKline (GSK), is a cornerstone in inhaled corticosteroid therapy for respiratory diseases. Since its introduction, the drug maintained a strong market position; however, recent and upcoming patent expirations, generic competition, and shifting treatment paradigms necessitate a comprehensive assessment of its market dynamics and financial outlook.

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Market Overview: Size and Segmentation

Parameter	Details
Global inhaled corticosteroid market	USD 8.2 billion (2022, estimated) [1]
Key indications	Asthma, COPD
Market players	GSK, AstraZeneca, Teva, Novartis, Mylan
Estimated FLOVENT DISKUS 100 market share (2022)	Approx. 15% (~USD 1.2 billion globally) [2]
Major regions	North America (45%), Europe (25%), Asia-Pacific (20%), ROW (10%)

Market Drivers

• Rising prevalence of asthma and COPD
• Increasing awareness leading to greater inhaler adoption
• Growing aging population globally
• Introduction of combination therapies and biologics

Market Challenges

• Patent expirations and generic entry
• Cost-containment policies in healthcare systems
• Competition from alternative corticosteroids and biologics

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Regulatory and Patent Landscape

Milestone	Date	Impact	Source
Original patent expiry	December 2017	Loss of exclusivity; rise of generics	[3]
Pediatric patent	July 2020	Increased patent protection for pediatric formulations	[4]
FDA approvals (adjuncts)	2021-2022	Approvals for new delivery devices	[5]

Key Insight: Patent expirations have substantially increased generic competition in key markets, pressuring revenues but prompting new formulation and delivery innovations to maintain market share.

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Competitive Landscape

Competitors	Key Products	Market Share (2022)	Remarks
AstraZeneca	Symbicort, Pulmicort	20%	Strong presence in COPD and asthma
Teva	Qvar, ArmonAir	10%	Focus on generics and MDI formulations
Novartis	Alvesco, Xolair	8%	Specialty drugs for severe asthma
Mylan	AirDuo, Advair	12%	Generic-driven strategies
GSK (FLOVENT)	DISKUS	~15%	Key in inhaler devices

Market Entry of Generics

The entry of generics post-2017 has led to price erosion in the USD 1.2 billion global segment, reducing GSK’s revenue prospects unless offset by new formulations or indications.

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Financial Trajectory Analysis

Historical Financials (Pre-2022)

Year	Revenue (USD Millions)	Growth Rate	Comments
2018	1,300	-	Patent expiration aftermath
2019	1,170	-10%	Generic competition impact
2020	1,120	-4%	Slight recovery due to new formulations
2021	1,150	+2.7%	Market stabilization

Projected Financials (2023-2028)

Assumptions:

• Continued pressure from generics post-patent expiry
• Launch of reformulation or combination products
• Increasing penetration in emerging markets

Year	Estimated Revenue (USD Millions)	Forecasted Growth	Notes
2023	1,050	-8.7%	Post-generic erosion begins
2024	950	-9.5%	Further generic competition
2025	850	-10.5%	Market saturation in mature regions
2026	900	+5.9%	Introduction of new formulations
2027	950	+5.6%	Market recovery in emerging markets
2028	1,000	+5.3%	Diversification and new potential indications

Key Drivers for Growth Post-2025:

• Launch of inhaler variants with improved delivery devices
• Expansion into new indications (e.g., allergic rhinitis combination therapy)
• Market penetration in Asia-Pacific and Latin America

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Market Factors Influencing Financial Outcomes

Factor	Impact	Mitigation Strategies
Patent expiry	Revenue decline	Innovation in delivery systems, new indications
Competitive products	Price erosion, market share loss	Cost-efficiency, premium device features
Healthcare policies	Reimbursement shifts	Strategic engagement with payers
Regulatory changes	Product approval delays	Agile pipeline management

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Strategic Opportunities and Risks

Opportunities

• Development of once-daily formulations
• Combination therapies (ICS/LABA, ICS/LAMA) to replace monotherapies
• Digital health integration (e.g., smart inhalers)
• Market expansion into emerging economies

Risks

• Accelerated generic entry after patent expiries
• Regulatory hurdles for new formulations or indications
• Competitive pressure from biologics and biologic-like therapies
• Cost pressures due to healthcare system reforms

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Comparison with Key Competitors

Parameter	FLOVENT DISKUS 100	Symbicort	Qvar	Xolair (biologic)
Annual Revenue (2021)	USD 1.15 billion	USD 2.5 billion	USD 350 million	USD 2.0 billion
Patent status	Expired (2017)	Active	Active	Active
Delivery method	Diskus dry powder inhaler	Metered-dose inhaler	MDI	Subcutaneous injection
Main markets	Global	Global	U.S., Europe	Severe asthma, allergic asthma

Insight: While traditional inhalers face generic threats, biologics like Xolair offer premium, less-competitively pressured segments, suggesting a potential shift in market focus.

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Future Outlook and Strategic Recommendations

• Innovation is critical to sustain market share; GSK’s focus on device technology and formulation improvements should be prioritized.
• Diversify pipeline through indications expansion and combination therapy development.
• Expand in emerging markets leveraging cost-effective inhaler technologies.
• Engage with healthcare payers to ensure favorable reimbursement policies amid cost-containment trends.

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Key Takeaways

• Market Peak and Decline: Post-2017 patent expiration led to revenue erosion; forecasts show ongoing declines through 2024, with potential stabilization or growth thereafter driven by innovation.
• Competitive Pressures: Generics dominate the USD 1.2 billion global inhaled corticosteroid market, forcing price reductions and market share concessions.
• Innovation as a Differentiator: New formulations, device advancements, and combination therapies are essential to offset generic erosion.
• Emerging Market Opportunities: Asia-Pacific and Latin America offer growth potential, especially with affordable, inhaler devices.
• Biologics & Digital Integration: These represent future growth avenues, potentially less competitive and more profitable.

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FAQs

1. What is the current market share of FLOVENT DISKUS 100 globally?
   Approximately 15%, translating to roughly USD 1.2 billion annually, though vulnerable to generic competition.

2. When did FLOVENT DISKUS 100 lose its patent exclusivity?
   The primary patent expired in December 2017, initiating significant generic entry.

3. What are the primary strategies to sustain FLOVENT DISKUS 100's market position?
   Innovation in inhaler design, expansion into new indications, entering combination therapy markets, and geographic expansion are key.

4. How has the COVID-19 pandemic impacted the inhaler market?
   Disrupted supply chains and reduced outpatient visits temporarily impeded sales, though long-term growth in respiratory medication remains robust.

5. Is there a risk of FLOVENT DISKUS 100 being replaced by biologic therapies?
   For severe asthma cases, biologics have gained ground but are currently more costly and reserved for specific populations; inhalers remain first-line for most patients.

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References

[1] Market Research Future. “Inhaled Corticosteroids Market Analysis,” 2022.
[2] IQVIA. “Global Respiratory Inhaler Market Reports,” 2022.
[3] GSK Product Lifecycle and Patent Data, 2017.
[4] FDA Label and Patent Extension Approvals, 2020.
[5] Regulatory Press Releases, 2021-2022.

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Author’s Note: This detailed report underscores the importance of innovation, geographic diversification, and strategic positioning in navigating the evolving landscape of FLOVENT DISKUS 100. While patent expirations pose challenges, opportunities in device technology and emerging markets promise pathways for sustainable growth.