CLINICAL TRIALS PROFILE FOR FLOVENT DISKUS 50

All Clinical Trials for FLOVENT DISKUS 50

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00120978 ↗	Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial	Unknown status	GlaxoSmithKline	Phase 4	2004-12-01	Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
NCT00120978 ↗	Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial	Unknown status	University of British Columbia	Phase 4	2004-12-01	Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
NCT00452348 ↗	A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma	Completed	GlaxoSmithKline	Phase 4	2007-05-01	This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Clinical Trial Conditions for FLOVENT DISKUS 50

Condition Name

Condition Name for FLOVENT DISKUS 50
Intervention	Trials
Asthma	16
Bioequivalence	2
Mild Asthma	1
Mild Intermittent Asthma	1

Condition MeSH

Condition MeSH for FLOVENT DISKUS 50
Intervention	Trials
Asthma	15
Respiratory Aspiration	3
Blister	3
Hypersensitivity	1

Clinical Trial Locations for FLOVENT DISKUS 50

Trials by Country

Trials by Country for FLOVENT DISKUS 50
Location	Trials
United States	199
Canada	13
Brazil	8
Greece	4
Argentina	4

Trials by US State

Trials by US State for FLOVENT DISKUS 50
Location	Trials
Florida	10
Texas	7
Pennsylvania	7
Ohio	7
Missouri	7

Clinical Trial Progress for FLOVENT DISKUS 50

Clinical Trial Phase

Clinical Trial Phase for FLOVENT DISKUS 50
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for FLOVENT DISKUS 50
Clinical Trial Phase	Trials
Completed	14
Recruiting	2
Terminated	1

Clinical Trial Sponsors for FLOVENT DISKUS 50

Sponsor Name

Sponsor Name for FLOVENT DISKUS 50
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	6
Teva Branded Pharmaceutical Products, R&D Inc.	4
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for FLOVENT DISKUS 50
Sponsor	Trials
Other	29
Industry	24
NIH	2

Flovent Diskus 50: Patent Landscape and Market Outlook

Last updated: February 19, 2026

This report analyzes the patent landscape surrounding Flovent Diskus 50 (fluticasone propionate) and projects its market trajectory. Key patent expirations and potential generic competition are assessed.

What is Flovent Diskus 50?

Flovent Diskus 50 is an inhaled corticosteroid (ICS) used for the maintenance treatment of asthma. It contains fluticasone propionate, a synthetic corticosteroid with potent anti-inflammatory properties. The Diskus device is a dry powder inhaler designed for efficient drug delivery to the lungs.

Mechanism of Action

Fluticasone propionate acts by reducing inflammation in the airways. It inhibits the production of inflammatory mediators, such as cytokines and chemokines, which are key contributors to airway hyperresponsiveness and the pathological changes seen in asthma. This reduction in inflammation leads to improved lung function and decreased asthma symptoms.

Dosage and Administration

Flovent Diskus 50 delivers a dose of 50 micrograms (mcg) of fluticasone propionate per inhalation. It is typically administered once or twice daily. The Diskus device contains 60 or 120 blisters, each with a single dose.

Indications

The primary indication for Flovent Diskus 50 is the long-term, daily management of asthma in patients aged 4 years and older. It is not intended for the relief of acute bronchospasm.

Flovent Diskus 50 Patent Expirations and Generic Entry

The patent protection for Flovent Diskus 50 has largely expired, paving the way for generic competition. Understanding these expirations is critical for market forecasting and strategic planning.

Key Patent Expirations

The primary patent covering the fluticasone propionate active pharmaceutical ingredient (API) expired in the United States in 2009. [1] Further patents related to specific formulations and the Diskus device have also expired. For example, patents covering the Diskus inhaler device, which is crucial for the product's delivery mechanism, have reached their expiration dates. [2]

Impact of Generic Competition

The expiration of primary patents has already led to the introduction of generic versions of fluticasone propionate inhalers. These generics typically offer a lower price point, leading to significant market share erosion for the branded product. Generic manufacturers often leverage their ability to produce the drug at a lower cost due to less expenditure on R&D and marketing.

Regulatory Pathways for Generics

Generic drug manufacturers must demonstrate bioequivalence to the reference listed drug (RLD), which in this case is Flovent Diskus 50. This is achieved through Abbreviated New Drug Applications (ANDAs) submitted to regulatory agencies like the U.S. Food and Drug Administration (FDA). [3] Once approved, generic versions become available, directly competing with the branded product.

Market Analysis of Flovent Diskus 50 and its Generics

The market for inhaled corticosteroids, including fluticasone propionate, is substantial but highly competitive. The introduction of generics has reshaped the market dynamics.

Historical Market Share and Revenue

Prior to widespread generic entry, Flovent Diskus was a leading product in the asthma treatment market, generating significant revenue for its manufacturer. For instance, in 2009, GlaxoSmithKline reported substantial sales for Flovent. [4] However, as generic alternatives became available, its market share and revenue have declined.

Current Market Landscape

The current market is characterized by the presence of multiple generic fluticasone propionate inhalers across various inhaler devices. Pricing is a primary differentiator, with generics typically priced 30-70% lower than the branded product. [5] The choice of inhaler device also plays a role, with different generics potentially utilizing alternative delivery systems.

Key Market Drivers

• Asthma Prevalence: The continued high prevalence of asthma globally remains a primary driver for the ICS market. [6]
• Generic Pricing: The cost-effectiveness of generic fluticasone propionate makes it accessible to a broader patient population and encourages its adoption by payers and healthcare providers.
• Clinical Equivalence: The proven clinical equivalence of approved generic fluticasone propionate products reduces concerns about efficacy and safety compared to the branded version.
• Healthcare Policy: Reimbursement policies and formulary preferences often favor generic medications, further accelerating their uptake.

Market Restraints

• Physician and Patient Preference: Some physicians and patients may maintain a preference for the branded product due to familiarity or perceived device advantages, although this is diminishing.
• Complex Inhaler Devices: The development of complex, multi-dose inhaler devices can present challenges for generic manufacturers seeking to replicate the exact delivery mechanism. However, many generics have successfully navigated this by developing their own compatible or alternative devices.

Market Projection for Flovent Diskus 50 and Fluticasone Propionate Generics

The market for fluticasone propionate is expected to remain stable, with generics dominating.

Projected Market Growth

The overall market for inhaled corticosteroids is projected to grow at a modest rate, driven by increasing asthma diagnoses and a greater understanding of the benefits of long-term ICS therapy. [7] Within this market, fluticasone propionate generics are expected to maintain or slightly increase their share due to their established efficacy and cost advantage. The projected compound annual growth rate (CAGR) for the global ICS market is approximately 3-5% over the next five years. [8]

Competitive Landscape Evolution

The competitive landscape will continue to be dominated by generic manufacturers. Companies that can offer the lowest price points while maintaining supply chain reliability will likely capture the largest market share. Innovation in inhaler device technology may offer some differentiation, but the core API is off-patent.

Opportunities for Stakeholders

• Generic Manufacturers: Continued market penetration by optimizing manufacturing costs and distribution channels. Development of patient-friendly and cost-effective inhaler devices.
• Payers and Healthcare Providers: Leverage the availability of low-cost generics to manage healthcare expenditures for asthma treatment.
• Patients: Access to affordable and effective asthma maintenance therapy.

Challenges for Stakeholders

• Branded Manufacturer: Continued decline in market share and revenue as generic competition intensifies. Focus may shift to other therapeutic areas or next-generation respiratory products.
• New Entrants: Barriers to entry for new generic manufacturers may include established supply agreements and the need for efficient manufacturing processes.

Key Takeaways

• The patent protection for Flovent Diskus 50 has largely expired, allowing for widespread generic competition.
• Generic fluticasone propionate inhalers have significantly impacted the market share and revenue of the branded product.
• The market is driven by high asthma prevalence and the cost-effectiveness of generic ICS.
• The market for fluticasone propionate is projected to remain stable, with generics dominating due to pricing advantages.

Frequently Asked Questions

1. When did the primary patent for fluticasone propionate expire in the United States? The primary patent for the fluticasone propionate active pharmaceutical ingredient expired in the United States in 2009.
2. What is the regulatory pathway for generic fluticasone propionate inhalers? Generic manufacturers must obtain Abbreviated New Drug Application (ANDA) approval from regulatory bodies like the FDA, demonstrating bioequivalence to the reference listed drug.
3. How do generic prices typically compare to branded Flovent Diskus 50? Generic fluticasone propionate inhalers are generally priced 30-70% lower than the branded product.
4. What are the main drivers for the continued market demand for fluticasone propionate? The primary drivers are the high global prevalence of asthma and the cost-effectiveness of generic fluticasone propionate.
5. What is the projected market growth rate for the overall inhaled corticosteroid market? The global inhaled corticosteroid market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] Patent expiry data is publicly available through patent databases such as Google Patents and USPTO patent search. Specific patent numbers and their expiration dates would require detailed database queries. [3] U.S. Food and Drug Administration. (2020). Generic Drugs Program. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-program [4] GlaxoSmithKline. (2010). Annual Report and Form 20-F 2009. [Specific page numbers not available without direct access to the report]. [5] Industry market research reports on the respiratory drug market often provide these pricing comparisons. Specific reports vary by publisher. [6] Global Initiative for Asthma. (2023). GINA Report, Global Strategy for Asthma Management and Prevention. Retrieved from https://ginasthma.org/ [7] Market research reports on the respiratory drug market. (e.g., various reports from Grand View Research, MarketsandMarkets). [8] Ibid.