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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYRENIUM (triamterene) is an oral potassium-sparing diuretic approved in 1964 that works by inhibiting sodium reabsorption in the distal renal tubule, thereby conserving potassium while promoting natriuresis. It is indicated for edema associated with congestive heart failure, cirrhosis, and nephrotic syndrome. The drug has a relatively modest diuretic effect and onset of action within 2-4 hours.
$0.283MPart D
LOE ApproachingThis legacy product approaching loss of exclusivity signals a declining brand with minimal team expansion opportunity and focus on managed care and generic transition planning.
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)
Worked on DYRENIUM at Biocon? 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.