Last updated: February 26, 2026
What Is the Drug Associated with NDC 59572-0502?
NDC 59572-0502 corresponds to Sodium Zirconium Cyclosilicate, marketed as Lokelma. It is approved by the FDA for treating hyperkalemia in adult patients. The drug functions as a selective potassium trap within the gastrointestinal tract, reducing serum potassium levels.
Current Market Landscape
Indications and Usage
- Approved for hyperkalemia in adults.
- Used in hospital and outpatient settings.
- Marketed as a long-term therapy alternative to traditional potassium binders.
Competitors
- Sodium Polystyrene Sulfonate (Kayexalate): Older, less selective, with variable efficacy.
- Patiromer (Veltassa): Approved in 2017, more selective, fewer GI side effects.
- Zirconium-based agents (like Lokelma): Newer, targeted, with promising safety profiles.
Market Size
- Estimated global hyperkalemia treatment market was valued at approximately USD 500 million in 2022.
- The U.S. accounts for roughly 60% of the global market, estimated USD 300 million in 2022.
- Compound annual growth rate (CAGR) from 2022 to 2027 projected at 7.5%.
Adoption Factors
- Increasing prevalence of chronic kidney disease (CKD), heart failure, and diabetes.
- Shift from older, less selective agents toward newer therapies like Lokelma and Patiromer.
- Reimbursement trends favoring outpatient management with newer agents.
Price Analysis
Current Pricing (U.S. Market)
- Lokelma: Wholesale acquisition cost (WAC) approximately USD 260–300 per 10-gram sachet.
- Typical prescription includes 30-60 grams per day.
- Monthly treatment costs range from USD 780 to USD 1,800 depending on dosage and duration.
| Parameter |
Value |
| Average WAC per 10g |
USD 280 |
| Daily dosage (grams) |
30–60 |
| Monthly cost |
USD 780–1,800 |
| Reimbursement rate |
Usually 85–100% depending on payer |
Pricing dynamics
- Price per dose remains stable due to limited competition and patent exclusivity.
- Reimbursement levels influence net pricing for payers and providers.
- Price erosion expected to be minimal in the short term due to patent protection until at least 2028.
Potential for Price Fluctuation
- Introduction of biosimilars or generics would significantly impact pricing.
- Patent expiration currently scheduled for 2028.
- Market entry of alternative therapies could pressure pricing and market share.
Market Penetration & Future Growth
Expansion Opportunities
- Increased use in outpatient and chronic management settings.
- Broader indications, such as hyperkalemia caused by medication or comorbid conditions.
- Geographic expansion to Europe and Asia, where hyperkalemia prevalence is high.
Regulatory & Reimbursement Trends
- Coverage expanding with Medicare and private insurers emphasizing outpatient therapy.
- Value-based contracts potentially linked to patient outcomes.
Pricing Projections (2023-2027)
| Year |
Estimated Average Monthly Price |
Key Drivers |
| 2023 |
USD 780–1,800 |
Stable patent protection, steady demand |
| 2024 |
USD 780–1,780 |
Slight downward pressure from negotiations |
| 2025 |
USD 750–1,700 |
Competition increases, generic entry risk |
| 2026 |
USD 720–1,650 |
Patent expiration approaches, new competitors |
| 2027 |
USD 700–1,600 |
Market saturation, biosimilar threat |
Key Market Dynamics
- Price stabilization until patent expiry.
- Growth driven by aging populations and increased CKD prevalence.
- Competitive pressure from emerging therapies and biosimilars anticipates moderate price declines post-2028.
Conclusion
Lokelma (NDC 59572-0502) stands as a premium-priced, high-demand therapy for hyperkalemia, supported by growth in target patient populations. Its pricing sustains due to patent exclusivity and limited competition. The market is projected to grow at a CAGR of approximately 7.5% through 2027, with prices maintained through 2024–2025, followed by gradual declines as generics and biosimilars enter.
Key Takeaways
- The current U.S. market average monthly treatment cost for Lokelma is USD 780–1,800.
- Market growth driven by increased CKD and heart failure prevalence.
- Patent expiration slated for 2028, with potential price declines thereafter.
- Moderate competition from older binders like Kayexalate and newer agents like Patiromer influences pricing.
- Expansion into international markets presents additional revenue opportunities.
FAQs
1. What factors influence the pricing of Lokelma?
Pricing is influenced by patent protection, demand, reimbursement policies, and competition. Reimbursement rates and negotiations greatly impact net revenue.
2. How will patent expiration affect Lokelma’s market price?
Patent expiry in 2028 may lead to generic competition, likely reducing prices by 20–50% over the subsequent two years.
3. Are there upcoming competitors that could alter the market landscape?
Yes. Biosimilars and newer potassium binders are under development, potentially disrupting current pricing and market share.
4. How significant is the role of reimbursement in the drug’s market penetration?
Reimbursement policies influence prescribing patterns; higher reimbursement rates promote wider adoption, supporting higher prices.
5. What are the growth prospects in international markets?
Emerging markets with high CKD and cardiovascular disease prevalence could offer substantial growth opportunities if regulatory pathways are established.
References
- U.S. Food and Drug Administration. (2020). FDA approves sodium zirconium cyclosilicate (Lokelma) for treatment of hyperkalemia. Retrieved from https://www.fda.gov
- MarketWatch. (2023). Hyperkalemia treatment market size and growth forecast.
- IQVIA. (2022). National Prescription Data.
- EvaluatePharma. (2022). 2022 World Preview: Outlook to 2027.
- U.S. Centers for Disease Control and Prevention. (2022). Chronic Kidney Disease Surveillance Report.
