NDAORALSOLUTION
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
6/8 — Strong
PHOSLYRA (calcium acetate) by Fresenius Kabi is (calcium acetate capsules) when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration. Approved for chronic kidney disease, peritoneal dialysis. First approved in 2011.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PHOSLYRA is an oral calcium acetate solution approved in 2011 for managing hyperphosphatemia in chronic kidney disease and dialysis patients. It works by binding dietary phosphate in the gastrointestinal tract to form an insoluble complex that is excreted in feces, thereby lowering serum phosphorus levels. The mechanism is simple but clinically essential for patients whose kidneys can no longer regulate phosphate balance.
$0.388MPart D
Peak3.8 years to LOEProduct is at peak lifecycle with modest Part D spending ($388K in 2023) and minimal claim volume, indicating a niche market with stable but limited growth potential and smaller commercial teams.
Mechanism of Action
(calcium acetate capsules) when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Indications (2)
Clinical Trials (1)
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
Started Dec 2004
138 enrolled
Peritoneal DialysisChronic Kidney Disease
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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.