NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Aug 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
UROCIT-K (potassium citrate) by Mission Therapeutics is orally, the metabolism of absorbed citrate produces an alkaline load. First approved in 1985.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UROCIT-K (potassium citrate) is an oral extended-release tablet that prevents kidney stone formation by raising urinary pH and citrate levels, making urine less conducive to crystallization of stone-forming salts. It works by metabolizing absorbed citrate to produce an alkaline load that increases urinary citrate clearance and modifies renal handling of citrate. Indicated for patients at risk of recurrent kidney stones, particularly those with low urinary citrate or hypocitraturia.
$0.113MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending ($113K) and limited claims volume, indicating a mature, niche specialty market with potential for consolidation or de-emphasis.
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.