NDAINHALATIONPOWDER
Approved
Oct 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
BRONCHITOL (mannitol) by Otsuka is 12. First approved in 2020.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRONCHITOL is an inhaled mannitol powder approved for cystic fibrosis patients to improve pulmonary function. The mechanism of action remains unknown, though it demonstrates clinical benefit in CF airway clearance. It is administered as a dry powder inhaled directly to the lungs.
$0.124MPart D
LOE Approaching1.4 years to LOEVery limited commercial scale with minimal Part D penetration signals a niche specialty product with small brand team structure.
Mechanism of Action
12.1 Mechanism of Action The precise mechanism of action of BRONCHITOL in improving pulmonary function in cystic fibrosis patients is unknown. 12.2 Pharmacodynamics The pharmacodynamics of mannitol are unknown. 12.3 Pharmacokinetics Absorption Following oral inhalation of 635 mg, the mean mannitol…
Indications
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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.