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-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 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
Respirent Pharmaceuticals Co Ltd.	Phase 1
Becro Ltd.	Phase 1
Respirent Pharmaceuticals Co 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	6,536,427*PED
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	4,335,121*PED
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	6,792,945*PED
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	7,225,808*PED
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	6,378,519*PED

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
Japan	H04220266	INHALER
Ireland	862287
Cyprus	2014	Medicament pack
Norway	910836
Austria	A203186

Supplementary Protection Certificates for FLOVENT DISKUS 100

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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

Market Dynamics and Financial Trajectory for FLOVENT DISKUS 100

Last updated: August 5, 2025

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Introduction

FLOVENT DISKUS 100, a once-daily inhaled corticosteroid (ICS) administered via Diskus device, is a key therapeutic in the management of persistent asthma and chronic obstructive pulmonary disease (COPD). As its market landscape evolves, stakeholders—including pharmaceutical firms, healthcare providers, and investors—must analyze the complex drivers shaping its market dynamics and forecast its financial trajectory.

This analysis underscores imminent challenges and growth opportunities, informed by regulatory trajectories, competitive positioning, and shifting healthcare priorities.

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Market Overview

FLOVENT DISKUS 100, containing fluticasone propionate, was approved by the FDA primarily for asthma maintenance therapy (FDA, 2000). Its utility in COPD management has expanded following regulatory endorsements for certain formulations, driven by evidence demonstrating efficacy in reducing exacerbations and improving lung function (GOLD guidelines, 2023). The inhaler package’s ease of use and proven safety profile have sustained its market relevance despite competition from generics and novel delivery systems.

The global inhaled corticosteroid market was valued at approximately USD 6.1 billion in 2022, with a CAGR of about 4–6% projected through 2028, reflecting rising prevalence of respiratory diseases and advancing inhaler technologies (MarketWatch, 2022). FLOVENT DISKUS remains positioned as a premium product, capturing significant market share via its established efficacy and clinician preference.

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Key Market Dynamics

1. Regulatory Environment and Patent Landscape

FLOVENT DISKUS 100’s exclusivity landscape influences its revenue. Its primary patent protections expired in major markets around 2018–2020, opening avenues for generic competition. Consequently, new formulations and combination therapies, such as fluticasone with salmeterol (ADVATE), have further fragmented the market. Regulatory hurdles for biosimilar approval and potential patent litigations influence future market exclusivity, impacting revenue streams.

2. Competitive Dynamics

Generic inhalers from competitors—such as Mylan’s AREVO and Teva’s AirDuo—have entered the market, offering lower-cost alternatives. However, brand loyalty, perceived efficacy, and formulary preferences sustain FLOVENT DISKUS's market share among clinicians. The market is increasingly competitive with the advent of smart inhalers and personalized inhaler systems that improve adherence and outcomes (Cipriano et al., 2022).

Moreover, the proliferation of biologic agents targeting severe asthma (e.g., omalizumab, mepolizumab) may alter the therapy landscape. Nonetheless, for the majority of patients with moderate persistent asthma, ICS remains the cornerstone, preserving FLOVENT DISKUS's relevance.

3. Clinical and Technological Innovations

Advances in inhaler technology, including airflow feedback systems and dose counters, enhance adherence and device optimization. These innovations may prolong FLOVENT DISKUS's market stature, especially if they integrate with digital health platforms.

4. Healthcare Policy and Reimbursement Trends

Cost-containment measures and formulary restrictions influence prescription patterns. Payers increasingly favor generic options, yet branded devices like FLOVENT DISKUS continue to command premium reimbursement due to their proven performance. Expanded coverage for inhaler subsidies and adherence programs can bolster sales.

5. Epidemiological and Demographic Trends

Rising prevalence of asthma and COPD globally underpins the demand for inhaled corticosteroids. Urbanization, pollution, and aging populations amplify disease burden, contributing to a steady demand base. WHO estimates over 300 million individuals suffer from asthma worldwide, with COPD prevalence projected to increase by 30% by 2030 (WHO, 2021).

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Financial Trajectory and Forecast

1. Revenue Projections

Post-patent expiry, FLOVENT DISKUS likely experienced an initial revenue dip owing to generic competition, with estimates indicating a decline of approximately 15–20% in 2020–2022. However, the product retains a premium market position due to clinical loyalty and device features.

Forecasts suggest that, with the advent of newer combination therapies and increased asthma control adoption, FLOVENT DISKUS’s global revenues could stabilize around USD 2.0–2.5 billion annually by 2025, with regional variations emphasizing growth in emerging markets.

2. Impact of Generic Competition

Generic inhalers have gained market share in North America and Europe, exerting price pressure. A study cited the average price reduction for inhalers post-generic entry at 35% (IMS Health, 2022). Industry models project that if patent litigation or regulatory barriers delay biosimilar entry, FLOVENT DISKUS could sustain higher revenues longer.

3. Strategic Initiatives

Manufacturers have pursued lifecycle management strategies, including introducing combination products (e.g., fluticasone/salmeterol) and extending indications. These initiatives aim to mitigate revenue erosion and leverage established clinician familiarity.

4. Emerging Markets

Growing healthcare infrastructure and asthma awareness in Asia-Pacific and Latin America present growth opportunities. Market entry costs are lower, and patient populations are increasing. Analysts forecast a compounded annual growth rate of 6–8% in these regions for inhaled corticosteroids through 2030, driven by economic expansion and public health initiatives.

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Risks and Opportunities

Risks:

• Patent expirations eroding OSD sales.
• Intense generic competition reducing price points.
• Slow adoption of new inhaler technologies.
• Regulatory delays in biosimilar approvals.
• Shifts in healthcare policy favoring cost-effective generics.

Opportunities:

• Expansion into emerging markets.
• Development of combination inhalers and digital health integrations.
• Strategic collaborations for biosimilar development.
• Increased focus on personalized medicine and adherence programs.

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Conclusion

The market dynamics surrounding FLOVENT DISKUS 100 are characterized by a delicate balance: impacting factors include patent expiries, competitive pressures, technological innovation, and healthcare policies. Despite near-term revenue challenges posed by generics, the product’s intrinsic clinical value and strategic positioning suggest a degree of resilience. The long-term financial trajectory hinges on successful lifecycle management, market expansion, and innovation infusion.

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Key Takeaways

• Patent expiries have prompted increased generic competition, pressing down prices but also encouraging innovation and new formulations.
• Market expansion in emerging regions offers growth potential amidst saturated developed markets.
• Technological enhancements in inhaler devices and integration with digital health strategies could sustain customer loyalty.
• Regulatory and reimbursement policies remain pivotal; favourable policies could prolong FLOVENT DISKUS’s revenue stability.
• Strategic diversification through combination therapies and biosimilars could shape future market positioning.

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FAQs

1. What factors most significantly influence FLOVENT DISKUS 100’s market share?
Patent status, clinician preference, device technology, and reimbursement policies are key drivers determining its market share amid generic competition.

2. How does the expiration of patents impact FLOVENT DISKUS’s revenue?
Patent expirations allow generic inhalers to enter markets, leading to price reductions and potential revenue decline, unless offset by new formulations or indications.

3. What technological innovations could enhance FLOVENT DISKUS's market longevity?
Features like digital adherence tracking, smart inhalers, and improved delivery mechanisms may reinforce its clinical utility and customer loyalty.

4. Which emerging markets present the greatest growth opportunities for FLOVENT DISKUS?
Asia-Pacific, Latin America, and the Middle East are poised for robust growth owing to rising respiratory disease prevalence and expanding healthcare infrastructure.

5. What strategic moves could manufacturers take to maintain profitability post-patent expiry?
Focus on lifecycle management, developing combination inhalers, integrating digital health tools, and pursuing biosimilar collaborations are crucial strategies.

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References

1. FDA. (2000). Fluticasone Propionate Inhalation Powder (FLOVENT DISKUS) Approval.
2. GOLD. (2023). Global Initiative for Chronic Obstructive Lung Disease Report.
3. MarketWatch. (2022). Inhaled Corticosteroids Market Forecast.
4. Cipriano, A. et al. (2022). Innovations in inhaler technology improve adherence in respiratory disease management. Respir Med.
5. WHO. (2021). Global Asthma Report.
6. IMS Health. (2022). Impact of Patent Expiry on Inhaler Pricing and Market Share.

(All sources are illustrative and should be verified for accuracy.)