NDAORALCAPSULE
Approved
Jun 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
MACRODANTIN (nitrofurantoin macrocrystals) by Almatica Pharma is mechanism of action the mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Approved for urinary tract infections, enterococci, staphylococcus aureus and 4 more indications. First approved in 1970.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MACRODANTIN is an oral nitrofuran antibacterial approved in 1970 for treating urinary tract infections caused by susceptible gram-negative and gram-positive organisms including E. coli, Klebsiella, Enterobacter, and Staphylococcus aureus. It works through a unique multi-target mechanism: bacterial flavoproteins reduce nitrofurantoin to reactive intermediates that inactivate ribosomal proteins and inhibit protein synthesis, DNA/RNA synthesis, aerobic metabolism, and cell wall synthesis. This broad-based mechanism explains the lack of acquired bacterial resistance.
$0.025MPart D
LOE ApproachingDeclining
Product is in late-stage decline with minimal claims volume; commercial teams face revenue preservation challenges and potential portfolio consolidation.
Mechanism of Action
Mechanism of Action The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other acromolecules. As a result of such…
Pharmacologic Class:
Nitrofuran Antibacterial
Indications (7)
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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.