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Aerospan Hfa (FLUNISOLIDE)
Flunisolide (Aerospan Hfa) is a marketed corticosteroid inhaler primarily indicated for the nasal symptoms of seasonal or perennial rhinitis, competing in a crowded market with several established same-class drugs. Its key strength lies in its mechanism of action, which effectively reduces inflammation and swelling in the airways by mimicking cortisol, providing targeted relief for rhinitis symptoms. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and potentially erode market share.
At a glance
| Generic name | FLUNISOLIDE |
|---|---|
| Sponsor | Ivax Res |
| Drug class | flunisolide |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1981 |
Approved indications
- Nasal symptoms of seasonal or perennial rhinitis
Common side effects
- Nasal burning and stinging
- Nasal congestion
- Sneezing
- Epistaxis and/or bloody mucous
- Nasal irritation
- Watery eyes
- Sore throat
- Nausea and/or vomiting
- Headaches
- Nasal septal perforations
- Temporary or permanent loss of the sense of smell and taste
- Hypercorticism (Cushings syndrome)
Key clinical trials
- Mentored Patient-Oriented Research Career Development Award (PHASE1)
- Effect of Physiotherapy in Hospitalized COPD Patients (NA)
- Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (NA)
- Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) (PHASE3)
- Flunisolide HFA in Children With Small Airway Disease (NA)
- Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aerospan Hfa CI brief — competitive landscape report
- Aerospan Hfa updates RSS · CI watch RSS