NDAORALSOLUTION
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
5/8 — Partial
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. First approved in 2011.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PHOSLYRA (calcium acetate) is an oral solution phosphate binder indicated for hyperphosphatemia management in patients with chronic kidney disease. The drug combines with dietary phosphate to form an insoluble calcium phosphate complex that is excreted in feces, effectively reducing serum phosphorus levels.
$0.388MPart D
LOE Approaching3.7 years to LOEProduct nearing patent expiration with stable but modest Medicare Part D utilization; commercial team likely focused on defending market share against generics.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Why This Matters for Your Career
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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.