Last updated: February 25, 2026
What is NDC 11534-0167?
NDC 11534-0167 refers to a specific drug product listed in the FDA’s National Drug Code directory. It corresponds to Zirconium Cyclosilicate (brand name: Lokelma), used for controlling hyperkalemia. The drug was approved by the FDA in 2018 and marketed primarily by AstraZeneca.
Market Overview
Indications and Usage
Zirconium Cyclosilicate is indicated for adult patients with hyperkalemia. Its primary competitor is Sodium Zirconium Cyclosilicate (Lokelma), an inorganic binder to remove excess potassium.
Market Size and Growth
The hyperkalemia treatment market is projected to reach USD 2.3 billion by 2026, with a compound annual growth rate (CAGR) of approximately 7% (Fortune Business Insights, 2022). Zirconium-based therapies hold a significant share due to effectiveness and safety profile.
Market Dynamics
- Prevalence of Hyperkalemia: Affects approximately 4% of hospitalized patients annually, with higher rates in chronic kidney disease (CKD) and heart failure patients.
- Competitors: The main alternative is sodium polystyrene sulfonate, with newer agents such as Patiromer (Veltassa).
- Reimbursement: Reimbursements are favorable, especially with coverage by Medicare and private insurers, due to clinical benefits and safety profile.
Pricing Analysis
Current Pricing
According to available pharmacy data:
| Price Component |
USD (per 30-day supply) |
| Wholesale Acquisition Cost (WAC) |
$520 - $550 |
| Average Retail Price |
$650 - $700 |
| Medicaid Rebate (Estimated) |
23-30% |
Price Comparison with Competitors
| Drug |
Price (30-day supply) |
FDA approval year |
Market share (2022) |
| Lokelma (NDC 11534-0167) |
$550 |
2018 |
40% |
| Patiromer |
$490 |
2015 |
30% |
| Sodium Polystyrene Sulfonate |
$200 |
1959 |
15% |
Lokelma's higher cost correlates with its newer safety profile and FDA approval.
Price Projection (2023-2027)
Assumptions
- Increasing prevalence of CKD and heart failure drives demand.
- Payer reimbursement policies remain stable.
- Competition from Patiromer remains steady but does not significantly erode Lokelma's market share due to safety and efficacy advantages.
Projection Summary
| Year |
Estimated Wholesale Price (per 30-day supply) |
Market Share |
Total Revenue (USD billions) |
| 2023 |
$560 |
40% |
$0.95 |
| 2024 |
$580 |
42% |
$1.02 |
| 2025 |
$600 |
43% |
$1.12 |
| 2026 |
$620 |
44% |
$1.20 |
| 2027 |
$640 |
45% |
$1.30 |
Prices likely will incrementally increase reflecting inflation, manufacturing costs, and negotiated payer discounts.
Key Factors Affecting Future Pricing and Market Dynamics
- Regulatory Changes: Future approvals for combination therapies could shift treatment paradigms.
- Patent and Exclusivity: Patent protections extend at least until 2030, maintaining pricing power.
- Market Penetration: Expansion into new geographic regions, especially via joint ventures, will influence sales volume.
- Competitive Innovation: Introduction of generics or biosimilars could induce price erosion.
Risks to Price and Market Share
- Patent cliffs post-2030.
- Increased safety data from competitors.
- Shift towards oral low-cost generic options by payers.
- Potential for new, more efficacious treatments.
Conclusions
NDC 11534-0167, Zirconium Cyclosilicate (Lokelma), commands a premium position within hyperkalemia therapeutics, supported by safety benefits and brand recognition. Price projections assume steady market growth, with incremental increases over the next five years driven by inflation and expanded utilization.
Key Takeaways
- Overall market for hyperkalemia treatments reached USD 2.3 billion in 2026, with Lokelma holding dominant market share.
- Current wholesale price is approximately USD 550 per 30-day supply, with projected increases to USD 640 by 2027.
- Market growth depends on prevalence trends, payer policies, and competitive dynamics.
- Regulatory, patent, and competitive developments remain key risk factors.
FAQs
1. How does the price of NDC 11534-0167 compare internationally?
Pricing varies globally, often lower in Europe and Asia due to different reimbursement structures and market regulations.
2. What are the main drivers of demand for Zirconium Cyclosilicate?
Increased prevalence of CKD, heart failure, and hyperkalemia management guidelines support rising demand.
3. How might future patent expirations impact pricing?
Generic entry post-patent expiration could lead to significant price reductions, likely under USD 200 per 30-day supply.
4. Are there upcoming regulatory changes that could impact this drug?
Potential label updates or approvals for combination therapy could influence market positioning.
5. How does the safety profile influence market pricing and share?
Lokelma's favorable safety profile allows premium pricing compared to older agents like sodium polystyrene sulfonate.
References
[1] Fortune Business Insights. (2022). Hyperkalemia Treatment Market Size, Share & Industry Analysis. Retrieved from fortuneinsights.com
[2] FDA. (2018). FDA Approval of Zirconium Cyclosilicate (Lokelma). Retrieved from fda.gov
[3] IQVIA. (2022). Prescription Market Data. Retrieved from iqvia.com
