NDAINHALATIONFOR SOLUTION
Approved
Feb 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
CAYSTON (aztreonam) by Gilead Sciences is 12. First approved in 2010.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAYSTON is an inhaled monobactam antibiotic (aztreonam) approved in 2010 for treating Pseudomonas aeruginosa airway infections in cystic fibrosis patients. It works by inhibiting bacterial cell wall synthesis through penicillin-binding protein interaction, with localized delivery to lung tissue achieving high sputum concentrations (mean 984 mcg/g) while minimizing systemic exposure. The drug exhibits activity against gram-negative aerobic pathogens and maintains efficacy in CF lung secretions.
$0.034BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D utilization (~2,758 claims in 2023) signals potential team consolidation and transition to generic/biosimilar preparation mode.
Mechanism of Action
12.1 Mechanism of Action Aztreonam is an antibacterial drug [see ] . 12.3 Pharmacokinetics Sputum Concentrations Sputum aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the…
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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.