CLINICAL TRIALS PROFILE FOR FLOVENT DISKUS 100

All Clinical Trials for FLOVENT DISKUS 100

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
NCT00452699 ↗	A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects 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 100

Condition Name

Condition Name for FLOVENT DISKUS 100
Intervention	Trials
Asthma	16
Bioequivalence	2
Mild Asthma	1
Mild Intermittent Asthma	1

Condition MeSH

Condition MeSH for FLOVENT DISKUS 100
Intervention	Trials
Asthma	15
Respiratory Aspiration	3
Blister	3
Lung Diseases, Obstructive	1

Clinical Trial Locations for FLOVENT DISKUS 100

Trials by Country

Trials by Country for FLOVENT DISKUS 100
Location	Trials
United States	199
Canada	13
Brazil	8
Greece	4
Argentina	4

Trials by US State

Trials by US State for FLOVENT DISKUS 100
Location	Trials
Florida	10
Missouri	7
California	7
Colorado	7
Texas	7

Clinical Trial Progress for FLOVENT DISKUS 100

Clinical Trial Phase

Clinical Trial Phase for FLOVENT DISKUS 100
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for FLOVENT DISKUS 100
Clinical Trial Phase	Trials
Completed	14
Recruiting	2
Terminated	1

Clinical Trial Sponsors for FLOVENT DISKUS 100

Sponsor Name

Sponsor Name for FLOVENT DISKUS 100
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 100
Sponsor	Trials
Other	29
Industry	24
NIH	2

Flovent Diskus 100 (fluticasone propionate) clinical trials update, market analysis, and exclusivity/projection outlook

Last updated: July 28, 2026

Flovent Diskus 100 (fluticasone propionate inhalation powder, 100 mcg strength) is an inhaled corticosteroid (ICS) for asthma maintenance therapy. From a market-and-IP perspective, it sits in a mature, largely generics-exposed category where revenue is driven by remaining branded share, payer contracting, and lifecycle management rather than new clinical differentiation. Clinical development activity for the “Diskus 100” strength is not the main driver of competitive dynamics; the competitive baseline is established by (1) generic fluticasone propionate/strength equivalents and (2) therapeutics that expand ICS-LABA and biologic penetration in asthma.

What clinical trials data are available for Flovent Diskus 100, and what do they show?

Short answer: Publicly disclosed, strength-specific, “Diskus 100” clinical outcomes are limited; the clinical evidence base is primarily the established fluticasone propionate dry powder inhaler (DPI) class effect in asthma maintenance, plus post-marketing safety and formulation/PK consistency work. Strength-specific incremental clinical endpoints rarely drive new labeling for existing strengths.

Which asthma endpoints are most relevant to Flovent fluticasone DPI use?

Common endpoints across ICS maintenance programs that support use of fluticasone DPIs include:

• Change from baseline in morning peak expiratory flow (AM PEF) and symptom scores
• Reduction in the rate of asthma exacerbations requiring systemic steroids
• Rescue medication use reduction
• Time to first exacerbation (in trials designed with exacerbation endpoints)
• Safety signals: adrenal suppression proxies (biomarkers), growth effects (pediatrics), dysphonia, oral candidiasis

Is there recent strength-specific “Diskus 100” trial activity that changes the competitive picture?

Not in a way that is identifiable as a commercially meaningful label expansion. In practice, remaining branded share tends to be protected by:

• Contracting and formulary positioning
• Patient/plan switching friction (device preference, pharmacy brand loyalty)
• Broader brand portfolios within fluticasone DPIs (other strengths and device formats)
• Patent and exclusivity on specific aspects (device, formulation, packaging, or combinations), if still active in the relevant jurisdiction and dosage form

How is Flovent Diskus 100 positioned in the asthma market, and what share drivers matter?

Short answer: The market is mature and price-competitive. Branded Flovent Diskus remains mainly a distribution and contracting story relative to generic fluticasone propionate DPIs, with growth constrained by:

• ICS-LABA substitution
• Step-therapy utilization management (particularly in commercial formularies)
• Uptake of biologics for severe asthma subpopulations

Key demand drivers in commercial and Medicare channels

1. Step therapy and prior authorization
   • Payers often require generic ICS first, then allow escalation to ICS-LABA or add-ons based on guideline-concordant criteria.
2. Switching costs
   • DPIs require inhalation technique. Device familiarity affects persistence.
3. Plan contracting
   • Net price erosion is the main commercial lever for older ICS products once generics are widely adopted.

Key demand headwinds

• Generic penetration: Fluticasone propionate inhaled products face substantial generic competition by strength/device.
• Therapy migration: Many patients are managed with fixed-dose ICS-LABA regimens, which can displace standalone ICS usage.
• Severe asthma segment shift: Biologics for phenotype-driven severe asthma reduce the total addressable pool for ICS-only therapy in the most expensive patient cohorts.

What is the competitive landscape for Flovent Diskus 100 (generics, devices, and alternatives)?

Short answer: The competitive set includes generic fluticasone propionate DPIs at comparable strengths, plus therapeutics that often outperform ICS monotherapy in payer and prescriber pathways, especially ICS-LABA and biologics.

Primary competitor categories

• Generic fluticasone propionate DPIs
  • Direct strength competition with Flovent Diskus 100.
• ICS-LABA inhalers
  • Often used earlier in asthma care for adherence and exacerbation reduction.
• ICS with add-on mechanisms
  • Separate classes include add-ons like LAMA in some regimens, though market adoption depends on clinical guidelines and payer policy.
• Biologics for severe asthma
  • Reduce demand for stepwise add-on ICS escalation in the severe subgroup.

Device substitution risk: DPI vs HFA vs other delivery systems

• Many patients are switchable between DPI and HFA devices.
• Prescriber selection and device education programs can shift utilization away from DPIs if generics or alternative devices are more favored on formulary.

When does Flovent Diskus 100 lose exclusivity, and what are the generic entry risks?

Short answer: Flovent Diskus 100 is in a late lifecycle state where exclusivity-based brand protection is largely exhausted or limited to residual, product-specific protections. The dominant generic entry and erosion risk is already manifest through widespread generic fluticasone penetration. Future risk is more about “last-man standing” market share for remaining branded channels rather than a first generic launch.

What kinds of IP still matter in a mature branded ICS?

Even if core active ingredient IP expired, residual protection can exist for:

• Specific dosage forms (DPI device features, dose uniformity or inhaler design)
• Specific formulation aspects (particle engineering, excipient systems)
• Packaging and method-of-use claims (less common for broad commercial displacement)
• Settlement and “authorized generic” dynamics in US Paragraph IV contexts

Paragraph IV risk mechanics in practice

For older inhaled products, “new” Paragraph IV filings typically target:

• Additional strengths
• Alternative device configurations under the same NDA
• Shorter remaining exclusivity windows (e.g., pediatric exclusivity already expired, but other statutory exclusivity may have had time-bound effects)

What is the Orange Book status of Flovent Diskus 100, and how many patents protect it?

Short answer: Flovent Diskus 100 is listed in the Orange Book for fluticasone propionate inhalation powder, but the number of currently relevant, enforceable patents for the 100 mcg strength is typically small and concentrated in secondary patents or formulation/device protections at this stage. The practical outcome is that generic competition is already established.

What you should expect from an Orange Book review for a mature ICS

An Orange Book table for fluticasone propionate inhalation products typically includes:

• Drug substance and composition patents
• Device or formulation process patents
• Method-of-use patents (if any)
• Expiration and exclusivity status for each listed patent

Because the user request is for an investment-grade market projection, the analysis hinges on current, live patent status. Without a contemporaneous Orange Book pull tied to the exact product (NDA, labeler, strength, and dosage form match), a precise patent-count and expiry schedule cannot be stated accurately here.

How strong is the patent estate for Flovent Diskus 100, and what does that mean for litigation?

Short answer: The patent estate strength is usually lower than it is for newer brand launches. Litigation risk generally shifts from “will a generic be allowed to enter?” to “how quickly will the market switch?” under settlements, launch timing, and authorized generic strategies.

Litigation patterns that typically affect branded ICS share

• Multi-party settlements among generic manufacturers and brand
• Co-promotion or authorized generic arrangements
• Staggered launches tied to patent expiry and court outcomes
• Narrowing of patent assertions or procedural dismissals

What are the FDA regulatory status considerations for Flovent Diskus 100?

Short answer: As an established NDA product, Flovent Diskus 100’s current regulatory relevance is mostly about:

• Ongoing pharmacovigilance and safety labeling updates
• Generic bioequivalence approvals for substitutable products
• Device and manufacturing changes under CMC supplements

What regulators look for in inhaled corticosteroid DPIs

• Aerodynamic performance and dose delivery consistency
• Particle size distribution stability through shelf life
• Uniformity, moisture protection, and device actuation reliability

What is the market outlook and revenue projection for Flovent Diskus 100?

Short answer: The revenue trajectory for Flovent Diskus 100 is expected to be flat-to-declining in real terms, driven by:

• Continued generic substitution and price erosion
• Limited clinical differentiation that would reverse channel migration
• Ongoing competition from ICS-LABA and, for severe asthma, biologics

A credible projection must be built from:

• Current US branded net sales trend by product strength
• Generic share and wholesaler channel movement
• Contracting dynamics and expected price per unit under tender and rebate frameworks
• Any live exclusivity or litigation/settlement triggers that affect launch timing

Without current-year sales and channel data for the exact “Flovent Diskus 100” strength, a quantified forecast cannot be produced to an operational standard.

How does Flovent Diskus 100 compare with Flovent HFA and other fluticasone presentations?

Short answer: Comparisons in the market typically show that:

• Device differences (DPI vs HFA) affect persistence and switching
• Formulary placement may differ by plan contracts and patient preference programs
• Net price differentials are driven by generic availability and contracting, not by efficacy differences in asthma maintenance

Where competition usually concentrates

• Pharmacy benefit managers often place whichever fluticasone presentation has the best net price under the plan’s preferred drug list.
• Device support programs can temporarily stabilize brand use but rarely change long-term economics in a generic-exposed category.

Key Takeaways

• Flovent Diskus 100 is a mature branded inhaled corticosteroid with competitive dynamics dominated by generic substitution and payer contracting rather than new clinical differentiation.
• Strength-specific “Diskus 100” clinical trial updates are not typically the primary driver of market share in this product lifecycle stage.
• Exclusivity and patent enforcement are not expected to be the main determinant of future revenue versus the established generic competitive baseline.
• Market outlook is expected to be flat-to-declining, with channel movement governed by net price, formulary status, and therapy migration to ICS-LABA and biologics.

FAQs

1. Does Flovent Diskus 100 have any remaining statutory exclusivity that could delay generic entry?
2. How do generic fluticasone propionate DPI products differ in device performance versus Flovent Diskus?
3. What formulary strategies protect branded fluticasone DPI share in Medicare Part D?
4. How does asthma guideline step therapy influence utilization of standalone ICS products like Flovent Diskus 100?
5. What CMC changes (device, particle engineering, packaging) most affect inhaled corticosteroid DPI substitution and switching?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and Labeling Information for fluticasone propionate inhalation products. U.S. Food and Drug Administration.