NDAINHALATIONAEROSOL, METERED2 Generics Approved
Approved
May 2004
Lifecycle
LOE Approaching
Competitive Pressure
55/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOVENT HFA is a metered-dose inhaler containing fluticasone propionate, a inhaled corticosteroid used to treat and prevent asthma symptoms. It works by reducing inflammation in the airways and improving breathing. The product is indicated for maintenance and acute asthma therapy across multiple patient populations.
$395MPart D
LOE Approaching2mo to LOEProduct approaching loss of exclusivity (August 2026) with $395M in annual Part D spending signals a contracting brand team and shift toward defensive commercial strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
Started May 2026
304 enrolled
Asthma
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
Started Dec 2024
724 enrolled
Asthma
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
Started May 2024
30 enrolled
Asthma
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Started Aug 2023
2,772 enrolled
Asthma
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Started Aug 2023
34 enrolled
Bioequivalence
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.