NDAINHALATIONFOR SOLUTIONPriority Review
Approved
Jun 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
NEBUPENT (pentamidine isethionate) by Fresenius Kabi is clinical pharmacology: microbiology mechanism of action studies suggest that the pentamidine isethionate interferes with microbial nuclear metabolism by inhibition of dna, rna, phospholipid and protein synthesis. First approved in 1989.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEBUPENT is an inhaled pentamidine isethionate solution indicated for Pneumocystis jiroveci pneumonia (PJP) prophylaxis and treatment in immunocompromised patients, primarily those with AIDS. The drug interferes with microbial nuclear metabolism by inhibiting DNA, RNA, phospholipid, and protein synthesis. It delivers high local lung concentrations via aerosol administration while maintaining minimal systemic exposure.
LOE Approaching
Product is nearing loss of exclusivity with limited commercial momentum; teams are likely focused on generic mitigation and niche market retention rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY: Microbiology Mechanism of Action Studies suggest that the pentamidine isethionate interferes with microbial nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis. However, the mode of action is not fully understood. Activity in vitro and in vivo…
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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.