NDAORALTABLET1 Generic Approved
Approved
Nov 1983
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
4/8 — Partial
FUROSEMIDE (furosemide) by Hikma is clinical pharmacology investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. First approved in 1983.
Drug data last refreshed 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Furosemide is a loop diuretic that inhibits sodium and chloride reabsorption primarily in the loop of Henle, proximal, and distal tubules. It is indicated for heart failure, pulmonary edema, hypertension, renal failure, and liver cirrhosis. The drug produces rapid onset diuresis (within 5 minutes IV, peak effect within 30 minutes) with a 2-hour duration of action.
LOE Approaching
As a mature, generic-competitive product approaching loss of exclusivity, furosemide teams focus on cost leadership, compliance support, and maintaining position through operational efficiency rather than market expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that furosemide inhibits primarily the reabsorption…
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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.