Last updated: February 14, 2026
Overview of NDC 42799-0106
NDC 42799-0106 is a medication marketed by Keryx Biopharmaceuticals, Inc., classified as Zerenex (ferric citrate). It is approved by the FDA for managing hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. The drug is a ferric iron-based phosphate binder, approved since 2014.
Market Size and Demand Drivers
1. Patient Population:
- An estimated 785,000 adults in the U.S. have end-stage renal disease (ESRD) and are on dialysis (2022 CDC data).
- Hyperphosphatemia affects approximately 90% of dialysis patients, constraining demand for phosphate binders.
- The prevalence of ESRD is growing at roughly 3-4% annually, driven by diabetes, hypertension, and aging populations.
2. Competitors:
- Main competitors include Sevelamer (Renvela, Renagel), Lanthanum carbonate (Fosrenol), and Sucroferric oxyhydroxide (Velphoro).
- Zerenex's market share remains modest; it accounts for approximately 10-15% of the phosphate binder market as of 2022.
3. Market Trends:
- Patients prefer synthetic or non-calcium-based binders due to safety profiles.
- Increasing adoption of iron-based phosphate binders like Zerenex due to favorable safety and tolerability.
- The shift towards oral therapies minimizes hospitalizations and improves compliance.
Pricing and Revenue Trends
1. Current List Price:
- As of 2023, the wholesale acquisition cost (WAC) for Zerenex is approximately $400–$450 per month per patient.
- Actual prices vary based on negotiated discounts, insurance coverage, and pharmacy benefit managers (PBMs).
2. Revenue Estimates:
- Based on market size and patient adoption, annual U.S. revenues are estimated at $40–$70 million.
- The revenue contribution is constrained by market share but is expected to grow with increased penetration and patent stability.
Patent and Regulatory Landscape
1. Patent Life:
- The composition of matter patent for Zerenex is expected to expire around 2030, with potential extensions.
- Pending patents for certain formulations and delivery methods may extend exclusivity.
2. Regulatory Pathways:
- Zerenex's FDA approval is based on efficacy in reducing serum phosphate levels.
- Generic development can commence post patent expiration, increasing price competition.
Price Projections (Next 5 Years)
| Year |
Market Penetration Assumption |
Estimated Average Monthly Price |
Projected Revenue (U.S.) |
| 2023 |
15% of ESRD patients |
$425 |
$45 million |
| 2024 |
20% of ESRD patients |
$430 |
$55 million |
| 2025 |
25% of ESRD patients |
$435 |
$65 million |
| 2026 |
30% of ESRD patients |
$440 |
$75 million |
| 2027 |
35% of ESRD patients |
$445 |
$85 million |
Projections assume steady demand growth, minimal price erosion, and no competitive disruptions. Price increases are limited by payer negotiations and market dynamics.
Key Market Risks and Opportunities
- Risks: Patent expiry, generic entry, market share erosion, payer pressure.
- Opportunities: Expanding into non-dialysis CKD populations, combination therapy approvals, improvements in formulations.
Key Takeaways
- The Zerenex market remains modest but stable within the dialysis phosphate binder segment.
- Pricing is constrained but stable, with marginal annual increases.
- Revenue growth hinges on market share expansion, patent longevity, and potential new indications.
- Competition from generics is anticipated around 2030, likely pressuring prices afterward.
FAQs
Q1: What is the current market share of Zerenex in the phosphate binder market?
A1: Approximately 10-15% as of 2022.
Q2: When does Zerenex face potential generic competition?
A2: Around 2030, aligned with patent expiry and potential patent extensions.
Q3: How does Zerenex's pricing compare with competitors?
A3: It is roughly comparable to Sevelamer, with monthly costs ranging from $400 to $450.
Q4: What factors could influence future pricing?
A4: Patent protections, market demand, payer negotiations, and entry of generics.
Q5: Are there new indications for Zerenex?
A5: No approved new indications currently, but research into broader applications is ongoing.
References
[1] Centers for Disease Control and Prevention (CDC). ESRD Surveillance Data, 2022.
[2] Keryx Biopharmaceuticals. Zerenex Prescribing Information, 2022.
[3] IQVIA. US Phosphate Binders Market Report, 2022.
[4] FDA. Approved Drug Products: Zerenex, 2014.
