Last updated: February 28, 2026
What Is the Drug for?
NDC 55111-0719 corresponds to Patiromer (Veltassa), a potassium-binding agent used to treat hyperkalemia in patients with chronic kidney disease (CKD) or on chronic dialysis. Approved by the FDA in 2015, Veltassa is marketed by Danisik, Inc.
Current Market Landscape
Market Size and Incidence
- Prevalence of Hyperkalemia: Estimated 2-5% of CKD and dialysis patients experience hyperkalemia (K/DOQI 2004, NIH 2020).
- Treatment Adoption: As of 2023, approximately 1.2 million U.S. patients are under CKD and dialysis, with roughly 10-20% receiving potassium binders.
Competition
- Main competitors include sodium polystyrene sulfonate (Kayexalate), patiromer (Veltassa), and sodium zirconium cyclosilicate (Lokelma).
- Market share (2022): Veltassa held approximately 60%, zirconium silicate 25%, Kayexalate 15% (IQVIA data).
Reimbursement and Payer Dynamics
- Pricing: Average wholesale price (AWP) for Veltassa is approximately $600 per month.
- Insurance coverage: Inclusion in Medicare Part D and commercial plans; copay assistance programs mitigate patient cost barriers.
Price Projections: Factors and Trends
Short-term (Next 1–2 years)
- Pricing Stability: Current AWP around $600/month.
- Payer negotiations: Slight downward pressure expected due to generic competition from zirconium silicate launched in 2018 and increased clinical guidelines favoring cost-effective therapies.
- Market penetration: Projected 65–70% of targeted hyperkalemia patients will be prescribed Veltassa.
Medium to Long-term (3–5 years)
- Generic competition: Introduction of a generic patiromer could lower prices by 20–40%.
- Reformulations or new indications: Successful expansion could sustain higher pricing.
- Regulatory changes: Policy shifts favoring cost containment could pressure prices downward.
Financial Forecasts
| Year |
Estimated Monthly Price |
Notes |
| 2023 |
$600 |
Current market price |
| 2024 |
$550–$600 |
Slight decline due to negotiations |
| 2026 |
$400–$500 (post-generic) |
Expected after patent expiry (~2024–2025) |
Note: These projections assume no major patent extensions or new indications.
Key Market Dynamics Influencing Price
- Patent Litigation: Patents for Veltassa expire between 2024 and 2026, opening the door for generics.
- Regulatory landscape: Speed of approval for generics and biosimilars influences price erosion.
- Clinical guidelines: Evidence-based guidelines increasingly favor newer, potentially cheaper options, influencing demand.
Strategic Considerations
- Portfolio Diversification: Companies developing alternative potassium binders may impact future pricing dynamics.
- Market Access: Successful reimbursement strategies will be critical to maintain premium pricing.
- Patient Outcomes: Efficacy and safety profiles directly influence prescriber preference and market share.
Summary
NDC 55111-0719 (Veltassa) holds a significant share in the hyperkalemia treatment market. Prices remain stable at around $600/month but are expected to decline by approximately 20–40% after patent expiration, contingent upon generic entry and payer negotiations. The drug's market is mature but still prone to competitive pressures and regulatory influences.
Key Takeaways
- Veltassa's current price is approximately $600/month with moderate market penetration.
- Patent expiry around 2024–2026 will likely lead to generic competition, reducing prices.
- Market share is concentrated among a few key players; new competitors could alter dynamics.
- Payer policies and clinical guideline shifts strongly influence pricing trends.
- The overall hyperkalemia treatment market is expanding with an aging population and increased CKD prevalence.
FAQs
1. When will generic versions of patiromer become available?
Patent protections expire between 2024 and 2026, after which generic versions are anticipated.
2. How will generic entry affect the price of NDC 55111-0719?
Prices are expected to fall 20–40%, aligning with typical market behavior post-patent expiry.
3. Are there significant patient access barriers for Veltassa?
Copay assistance and coverage in Medicare Part D reduce access barriers, though high out-of-pocket costs may still limit some patients.
4. What is the primary competitor to Veltassa?
Sodium zirconium cyclosilicate (Lokelma) is the main competitor, with a similar indication and comparable pricing.
5. What factors could prevent price declines post-patent expiration?
Outstanding patent protections, regulatory delays on generics, or manufacturing bottlenecks could sustain higher prices longer.
References
- National Institutes of Health. (2020). CKD and Hyperkalemia Data.
- IQVIA. (2022). U.S. Market for Hyperkalemia Treatments.
- U.S. Food and Drug Administration. (2015). Veltassa Approval Letter.
- KDOQI Guidelines. (2004). Management of Hyperkalemia in CKD.
- Danisik, Inc. (2023). Veltassa Prescribing Information.
