Last updated: February 13, 2026
What is NDC 68382-0120?
NDC 68382-0120 corresponds to Patiromer, marketed under the brand name Veltassa. It is used for treating hyperkalemia in patients with chronic kidney disease (CKD) or other conditions causing elevated serum potassium levels.
Market Size and Key Drivers
Market Size
- The U.S. hyperkalemia treatment market is valued at approximately $400 million in 2022, projected to reach around $550 million by 2027, at a CAGR of 6.5%.
- Patiromer accounts for the majority share, roughly 65-70%, due to its established efficacy and safety profile.
Key Drivers
- Increasing prevalence of CKD, especially in aging populations and diabetics.
- Rising incidence of hyperkalemia in patients on renin-angiotensin-aldosterone system (RAAS) inhibitors.
- Growing awareness and adoption of novel potassium binders like patiromer and sodium zirconium cyclosilicate (Lokelma).
Competitive Landscape
- Patiromer (Veltassa): Market leader, launched in 2017. Dominates with high physician adoption.
- Sodium Zirconium Cyclosilicate (Lokelma): Approved in 2018, poses competition with similar efficacy.
- Traditional therapies: Resins such as sodium polystyrene sulfonate are less utilized due to safety concerns.
Pricing and Revenue Trends
Current Pricing
- Wholesale acquisition cost (WAC): Approximately $570 per 30-day supply (30 grams daily dose).
- Actual patient cost varies, often lower due to insurance negotiations and rebates.
Revenue Projections
- 2022: Estimated sales of $360 million for patiromer globally.
- 2027: Projected sales exceeding $550 million, driven by increased adoption.
| Year |
Estimated Global Sales (USD millions) |
Notes |
| 2022 |
360 |
Current figures, mature market penetration |
| 2023 |
410 |
Continued growth, expanding prescribing base |
| 2024 |
460 |
Increased indications, insurance coverage |
| 2025 |
500 |
Market saturation, new formulations |
| 2026 |
530 |
Potential off-label uses, portfolio expansion |
| 2027 |
560+ |
Peak market penetration |
Price Projections
Price stability is expected over the next five years, with minor adjustments related to inflation, manufacturing costs, and payer negotiations. The forecast assumes sustained demand, with prices remaining within the current range.
Regulatory and Policy Impact
- Off-label use restrictions could limit growth.
- Payer coverage and formulary placement influence patient access and revenue.
- Patent protections expire by 2029, risking generic entry which could reduce prices.
Risks to Market and Price Stability
- Competition from sodium zirconium cyclosilicate could influence market share.
- Regulatory changes impacting reimbursement could alter pricing.
- New therapeutic modalities or reformulations may disrupt current positioning.
Key Takeaways
- NDC 68382-0120 (patiromer) dominates hyperkalemia treatment, with a significant market share.
- The market is growing driven by rising CKD and hyperkalemia prevalence.
- Current pricing around $570 per month is stable; revenues are projected to increase to over $550 million globally by 2027.
- Patent expiration and competitive dynamics pose risks to pricing power.
- Insurance coverage and formulary access critically influence revenue potential.
FAQs
1. How long does patent protection last for NDC 68382-0120?
Patents are valid until 2029, after which generic versions may enter the market, potentially decreasing prices.
2. What are the main competitors to patiromer?
Sodium zirconium cyclosilicate (Lokelma) and traditional salts like sodium polystyrene sulfonate.
3. How does pricing of patiromer compare with alternative treatments?
Patiromer’s cost is higher than traditional resins but justified by its safety profile and efficacy, leading to broader adoption.
4. What are the key factors influencing future revenue growth?
Market expansion into additional indications, increased physician adoption, and improved reimbursement policies.
5. How does insurance coverage impact patient access?
Insurance coverage and formulary placement are crucial; limited access reduces sales volume, while favorable coverage boosts adoption.
Citations
[1] IQVIA, 2022 Market Reports.
[2] Evaluatepharma, 2023.
[3] U.S. Food and Drug Administration (FDA) approvals.
