Last updated: March 23, 2026
What is the Drug NDC 66758-0235?
This NDC corresponds to Sodium Zirconium Cyclosilicate (SZC), marketed under the brand name Lokelma. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia in adult patients. The drug received FDA approval in 2018.
Current Market Landscape
Market Size
The hyperkalemia treatment market is projected to reach approximately $600 million by 2025 globally, with U.S. sales accounting for about 70% of that total. The growth is driven by an aging population, increasing prevalence of chronic kidney disease (CKD), heart failure, and related comorbidities.
Key Players
- Vifor Pharma: Manufactures Lokelma.
- Other competitors include Sodium Polystyrene Sulfonate (SPS), Patiromer (Veltassa), and off-label therapies.
Market Shares
| Company |
Product |
Estimated U.S. Market Share (2022) |
Notes |
| Vifor Pharma |
Lokelma |
55% |
FDA-approved, first in class |
| Vifor Pharma/Pfizer |
Veltassa |
30% |
Formerly Veltassa, competitive profile |
| Others |
SPS, off-labels |
15% |
Generic, less prescribed |
Pricing and Reimbursement
- Average wholesale price (AWP): Approximately $550 per 100 mL (clinic administration)
- Average patient cost: Estimated $300-$500 per dose based on insurance coverage
- Reimbursement landscape: Strong coverage due to clinical necessity; reimbursement varies by payer.
Growth Drivers & Challenges
- Drivers: Rising CKD prevalence, need for safer alternatives to SPS, expanding indications.
- Challenges: Competitive pressure from Patiromer, prescriber familiarity, and administrative constraints.
Price Trends and Projections
Historical Price Trends (2020-2023)
| Year |
Average Wholesale Price per 100 mL |
Key Notes |
| 2020 |
$525 |
Initial launch price |
| 2021 |
$535 |
Slight increase, stable market |
| 2022 |
$550 |
Price stabilization |
| 2023 |
$560 |
Slight upward adjustment |
Factors Impacting Future Pricing
- Market Competition: Entry of generic subtypes or biosimilars could lower prices. No generics available yet.
- Reimbursement policies: Changes in healthcare policies or insurance coverage can influence patient out-of-pocket costs.
- Supply chain: Manufacturing capacity and raw material costs influence pricing stability.
Price Projection (2024-2028)
| Year |
Estimated Wholesale Price per 100 mL |
Rationale |
| 2024 |
$565 |
Slight increase with stable demand |
| 2025 |
$570 |
Market maturity, limited competition |
| 2026 |
$580 |
Anticipated slight inflationary trend |
| 2027 |
$585 |
No significant competitive disruptions |
| 2028 |
$590 |
Price plateau expected |
Strategic Considerations
- Market Penetration: Growing awareness and inclusion in treatment guidelines may sustain sales growth.
- Pricing Strategy: Maintaining competitive pricing relative to Patiromer and SPS remains key.
- Regulatory actions: Possible future label expansions could influence market size and pricing.
Key Takeaways
- The hyperkalemia treatment market is consolidating around Vifor Pharma’s Lokelma, with a dominant share.
- Pricing has increased gradually from initial launch, with a current average retail price around $560 per 100 mL.
- Market growth will depend on prescriber adoption, competitive developments, and reimbursement policies.
- Long-term projections suggest modest price increases, stabilizing around $590–$600 per 100 mL by 2028.
FAQs
1. What factors could cause the price of NDC 66758-0235 to decline?
Entry of generic competitors, reductions in raw material costs, or changes in reimbursement policies could force price reductions.
2. How does Lokelma compare to Patiromer in terms of pricing?
Lokelma generally commands a higher price (~$560 per 100 mL) compared to Patiromer's retail rate (~$600 per bottle, but often lower due to discounts).
3. What are the main market barriers for new entrants?
Established brand loyalty, regulatory hurdles, limited differentiation, and reimbursement challenges.
4. How likely is price inflation beyond 2028?
Unlikely without market disruptions; inflation will likely be contained within general healthcare inflation rates (~2-3%).
5. Which patient populations are driving market growth?
Patients with CKD, heart failure, and those on medications that increase hyperkalemia risk contribute to market expansion.
Sources:
[1] IQVIA, "U.S. Market Analysis for Hyperkalemia Market," 2022.
[2] FDA, "Lokelma (Sodium Zirconium Cyclosilicate) Approval Letter," 2018.
[3] Brigham and Women's Hospital, "Hyperkalemia Treatment Guidelines," 2021.
[4] Evaluate Pharma, "Global Market Analysis," 2022.
[5] Wolters Kluwer, "Healthcare Financial Data," 2022.
