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. Approved for loop diuretic [epc]. First approved in 1983.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Furosemide is a generic loop diuretic used to treat fluid overload and edema associated with congestive heart failure, liver cirrhosis, and renal disease. It works by inhibiting sodium and chloride reabsorption in the ascending loop of Henle, promoting rapid urinary fluid excretion. This oral tablet formulation has been a standard-of-care diuretic for over four decades.
LOE Approaching
As an approaching LOE generic with moderate competitive pressure (45%), the brand team is likely focused on defending market share through operational efficiency rather than expansion.
Mechanism of Action
Pharmacologic Class:
Loop Diuretic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Bumetanide vs. Furosemide in Cirrhosis
Started May 2026
500 enrolled
Cirrhosis
A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)
Started Mar 2026
39 enrolled
Healthy
Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers
Started Feb 2026
16 enrolled
Healthy
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
Started Aug 2024
32 enrolled
Healthy
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants
Started Jul 2024
91 enrolled
Healthy Participants
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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.