NDAORALCAPSULE
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
6/8 — Strong
MACROBID (nitrofurantoin monohydrate/macrocrystalline) by Almatica Pharma is mechanism of action the mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Approved for pyelonephritis, perinephric abscesses. First approved in 1991.
Drug data last refreshed 15h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MACROBID is an oral nitrofuran antibacterial indicated for uncomplicated urinary tract infections including pyelonephritis and perinephric abscesses. It works through a unique multi-target mechanism wherein bacterial flavoproteins reduce nitrofurantoin to reactive intermediates that inhibit protein synthesis, energy metabolism, DNA/RNA synthesis, and cell wall formation. This broad-based mechanism has resulted in minimal acquired bacterial resistance over its 30+ year history.
$0.064BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D claims (~483 in 2023), suggesting a niche, stable commercial footprint with limited team expansion opportunities.
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 macromolecules. As a result of such…
Pharmacologic Class:
Nitrofuran Antibacterial
Indications (2)
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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.