NDAORAL, RECTALPOWDERPriority Review
Approved
Jun 1958
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
KAYEXALATE (sodium polystyrene sulfonate) by ANI Pharmaceuticals is potassium ion exchange activity [moa]. First approved in 1958.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KAYEXALATE is a sodium polystyrene sulfonate ion-exchange resin administered orally or rectally as a powder for the treatment of hyperkalemia. It works by binding potassium ions in the gastrointestinal tract, facilitating their excretion and reducing serum potassium levels. This is a legacy small-molecule therapeutic used primarily in nephrology and critical care settings.
LOE Approaching
Mature product with LOE approaching and competitive pressure at 30%; expect team consolidation and transition focus to generic transition management.
Mechanism of Action
Potassium Ion Exchange Activity
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on KAYEXALATE offers limited growth trajectory given LOE approaching status and zero linked job opportunities currently. Professionals joining this team should expect focus on defending market share, managing generic transition, and supporting legacy product optimization rather than expansion or innovation.
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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.