NDAORALCAPSULE
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MACROBID is an oral nitrofuran antibacterial approved in 1991 for treating uncomplicated urinary tract infections including pyelonephritis and perinephric abscesses. The drug works through a unique multi-target mechanism: bacterial reduction of nitrofurantoin produces reactive intermediates that simultaneously inhibit protein synthesis, energy metabolism, DNA/RNA synthesis, and cell wall synthesis. This broad mechanism explains the historical absence of acquired bacterial resistance.
$0.064MPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Medicare spending ($64K, 483 claims in 2023), indicating a mature, low-volume brand with limited commercial expansion opportunity.
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)
Worked on MACROBID at Almatica Pharma? Share your interview experience or compensation data (+7 days Pro)
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.