NDAORALCAPSULEPriority Review
Approved
Aug 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
DYRENIUM (triamterene) by Biocon is clinical pharmacology triamterene has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). Approved for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, the nephrotic syndrome and 5 more indications. First approved in 1964.
Drug data last refreshed 4h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYRENIUM (triamterene) is an oral potassium-sparing diuretic approved in 1964 that works by directly inhibiting sodium reabsorption in the distal renal tubule, promoting natriuresis and diuresis while conserving potassium. It is indicated for edema associated with congestive heart failure, cirrhosis, and nephrotic syndrome. The drug produces onset of action within 2–4 hours with peak serum levels at approximately 3 hours.
$0.283MPart D
LOE ApproachingDeclining
As a mature drug approaching loss of exclusivity with minimal Medicare utilization, the brand team is likely small and focused on maintaining existing prescriber relationships rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Triamterene has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). This activity is not directly related…
Pharmacologic Class:
Potassium-sparing Diuretic
Indications (8)
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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.