NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Aug 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
UROCIT-K (potassium citrate) by Mission Therapeutics is orally, the metabolism of absorbed citrate produces an alkaline load. Approved for nephrolithiasis, hypocitraturia. First approved in 1985.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UROCIT-K is an oral potassium citrate extended-release tablet approved in 1985 for nephrolithiasis and related urinary disorders. It works by increasing urinary pH and citrate excretion, reducing the crystallization of stone-forming salts like calcium oxalate and uric acid. The drug modifies renal handling of citrate to create urine less conducive to kidney stone formation.
$113KPart D
LOE ApproachingMature product with minimal spending signals a small, stable commercial team focused on retention rather than expansion.
Mechanism of Action
orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase…
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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.