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 1h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Potassium citrate is an oral alkalinizing agent used to prevent and treat kidney stone formation by raising urinary pH and citrate levels. It works by metabolizing absorbed citrate into an alkaline load that increases urinary citrate excretion and reduces the saturation of stone-forming salts (calcium oxalate, calcium phosphate, and uric acid). The drug is indicated for patients with recurrent kidney stones, renal tubular acidosis, and related urolithiasis conditions.
LOE Approaching
As a mature generic product approaching loss of exclusivity, the brand team is likely focused on defending market share against generic competition through patient support programs and physician relationships rather than growth initiatives.
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.