NDAINHALATIONPOWDER
Approved
Oct 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
BRONCHITOL (mannitol) by Otsuka is 12. Approved for cystic fibrosis. First approved in 2020.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRONCHITOL is an inhaled mannitol powder approved by the FDA in October 2020 for cystic fibrosis, with potential applications across multiple respiratory and neurological indications. The mechanism of action remains unknown, though it demonstrates improved pulmonary function in CF patients through unclear pharmacodynamic pathways. It is administered via inhalation and undergoes primarily renal elimination with minimal hepatic metabolism.
$124KPart D
Peak1.5 years to LOEMinimal Part D penetration ($124K spending) with only 32 claims in 2023 suggests early market adoption challenges; career growth potential limited unless uptake accelerates significantly before LOE.
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 (1)
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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.