NDAORALFOR SOLUTION
Approved
Oct 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
POTASSIUM CITRATE (potassium citrate) by PharmaIN is orally, the metabolism of absorbed citrate produces an alkaline load. First approved in 1988.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Potassium citrate is an oral electrolyte replacement therapy that increases urinary pH and citrate excretion to prevent kidney stone formation. It works by modifying renal handling of citrate and raising urinary alkalinity, which reduces the saturation of stone-forming salts like calcium oxalate and uric acid. The drug is indicated for patients with recurrent kidney stones, renal tubular acidosis, and chronic diarrheal syndromes.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a transition from growth to defensive positioning requiring cost-containment and market-share protection strategies.
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.