Last updated: February 25, 2026
What is NDC 50458-0609?
NDC 50458-0609 corresponds to Sodium Zirconium Cyclosilicate (ZS-9), a drug approved by the FDA in 2018 for the treatment of hyperkalemia in adults. It is marketed under the brand name Lokelma (formerly ZS-9). The drug acts as a selective potassium binder, reducing serum potassium levels.
Market Overview
Market Size and Growth
The hyperkalemia treatment market globally reached approximately $1.3 billion in 2022, with expectations to grow at a compound annual growth rate (CAGR) of 7.5% over the next five years. The primary drivers include aging populations, increased prevalence of chronic kidney disease (CKD), and expanding indications for hyperkalemia management.
Key Competitors
- Sodium Polystyrene Sulfonate (Kayexalate)
- Patiromer (Veltassa)
- Lokelma (NDC 50458-0609)
Lokelma gained significant FDA approval in 2018, capturing a share from traditional resins due to its improved safety profile and efficacy.
U.S. Market Penetration
As of 2022, Lokelma accounts for approximately 20-25% of the hyperkalemia treatment market, with increased adoption driven by clinical trials demonstrating better safety compared to older therapies.
Clinical Data and Adoption Trends
- Randomized trials indicate Lokelma reduces serum potassium within 1 hour in 89% of patients.
- It has a favorable safety and tolerability profile, with fewer gastrointestinal complications than older binders.
Pricing Analysis
Current Pricing Structure
- Average Wholesale Price (AWP): Approximately $600 for a 10-gram oral dose.
- Average Patient Cost: The out-of-pocket expense is roughly $60-$100 per dose, depending on insurance plans.
- Reimbursement: Medicare and commercial insurers reimburse approximately $550-$650 per dose.
Dose Regimen and Cost Implication
- Patients typically require two to four doses per day initially, tapering to one daily dose.
- Typical treatment costs range between $1,200 and $2,400 per month.
Price Competitiveness
Compared to older treatments like Kayexalate, which costs $10-$20 per dose but has safety concerns, Lokelma's higher cost is offset by improved safety and convenience.
Price Projections (2023-2028)
| Year |
Estimated Wholesale Price per Dose |
Expected Market Share |
Projected Revenue (USD) millions |
| 2023 |
$600 |
25% |
$350 |
| 2024 |
$620 |
30% |
$410 |
| 2025 |
$640 |
35% |
$470 |
| 2026 |
$660 |
40% |
$530 |
| 2027 |
$680 |
45% |
$590 |
| 2028 |
$700 |
50% |
$650 |
Forecast accounts for price inflation, market penetration, and competitive dynamics.
Factors Influencing Price and Market Share
- New indications: Expansion into other hyperkalemia-related conditions could elevate demand.
- Generic entry: No generics are expected within the next 3-5 years due to patent exclusivity until 2030.
- Reimbursement policies: CMS and insurance policies impact patient access and pricing.
Regulatory and Market Risks
- Potential competition from emerging therapies or improved formulations.
- Changes in reimbursement policies that could limit profit margins.
- Off-label use limitations could restrict market growth.
Strategic Opportunities
- Expand indications for chronic hyperkalemia management.
- Increase adoption in outpatient and long-term care settings.
- Differentiate through patient assistance programs to improve access.
Key Takeaways
- NDC 50458-0609 (Lokelma) dominates the modern hyperkalemia treatment market with a fast-growing share.
- Price per dose remains around $600, with annual treatment costs approaching $24,000.
- The market is expected to grow at a CAGR of 7.5% through 2028, driven by aging populations and chronic disease prevalence.
- No generics are expected in the near term, supporting sustained pricing power.
- Strategic focus should include market expansion and combating competitive threats.
FAQs
1. What are the primary drivers of Lokelma's market growth?
Aging populations, increased chronic kidney disease cases, and preference for safer, more effective treatments.
2. How does Lokelma's pricing compare with older therapies?
It costs significantly more than traditional resins but offers better safety, tolerability, and efficacy.
3. What factors could disrupt Lokelma's market share?
Emergence of new drugs, patent expiration, or changes in reimbursement policies.
4. What is the potential for future price increases?
Limited, due to market competition and regulatory oversight, but inflation adjustments are plausible.
5. How might expanded indications influence market size and pricing?
Broader indications can increase demand, potentially allowing for higher pricing or market penetration.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2018). Lokelma (sodium zirconium cyclosilicate) approval.
[3] EvaluatePharma. (2022). Hyperkalemia treatment market analysis.
[4] IMS Health. (2022). Pricing trends and reimbursement data.
[5] MarketWatch. (2023). Pharmaceutical industry forecast reports.
