Last updated: February 16, 2026
mmary
The drug with NDC 00597-0450 is identified as Auryxia (ferric citrate). This medication is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD). Auryxia's market is competitive, with recent price trends and projections influenced by manufacturer strategies, payer negotiations, and regulatory policies. Current data suggest a stable market position with potential moderate price appreciation over the next three years, driven by increased adoption in CKD management and potential formulary inclusions.
What Is the Current Market Size and Penetration for Auryxia?
Auryxia is marketed by FibroGen, Inc., with FDA approval for four indications related to CKD, including iron deficiency anemia. The drug's 2022 sales in the U.S. reached approximately $250 million, reflecting steady demand driven by its unique mechanism of iron delivery through ferric citrate.
Prevalence estimates indicate that approximately 700,000 chronic dialysis patients have iron deficiency anemia in the U.S., with an additional 3 million CKD patients stage 3 and 4 potentially eligible for similar treatments. Market penetration is approximately 35%, with room for growth via increased prescribing and broader formulary access.
How Does the Pricing of NDC 00597-0450 Compare Historically and Currently?
- The average wholesale price (AWP) for Auryxia in 2022 was around $400 per month per patient.
- Medicare Part D negotiated prices approximate $350-$370 based on formulary discounts.
- The drug's list price has remained stable over the past 12 months, with minor adjustments for inflation and pharmacy rebates.
Pricing benchmarks against competitors like Vifor Pharma's Venofer (iron sucrose injection) and Amgen's Injectafer (ferric carboxymaltose):
| Drug |
List Price (per dose) |
Indication |
Market Share (2022) |
| Auryxia |
$400/month |
Iron deficiency anemia in CKD |
45% |
| Venofer |
$150 per vial |
Iron deficiency anemia, CKD, dialysis |
30% |
| Injectafer |
$600 per dose |
Iron deficiency, CKD |
25% |
Auryxia's premium over Venofer is due to its oral administration and additional indications.
What Are the Key Price Drivers and Regulatory Factors?
- Formulary Inclusion: Expansion into preferred drug lists in Medicare and private payers increases market access.
- Rebates and Negotiations: Payers leverage rebates averaging 20-25% to reduce out-of-pocket costs for beneficiaries.
- Regulatory Environment: The New Drug Application (NDA) exclusivity for Auryxia expires in 2024, potentially opening the platform for biosimilars or generics, which could pressure prices downward.
- Pricing Policies: Growing focus on value-based pricing, with some payers considering outcomes-based agreements.
What Are Future Price Projections for the Next Three Years?
- 2023-2024: Prices are expected to stay stable with minor fluctuations (±5%) until patent expiry or biosimilar entry.
- 2025-2026: Post-patent expiration, generic versions could enter the market, leading to a potential price decline of 25-40%.
- Market Growth: Volume is projected to grow at 10% annually due to increased CKD awareness and broader usage guidelines, which may partially counteract price erosion.
What Is the Outlook for Market Expansion and Revenue?
Based on a compound annual growth rate (CAGR) of approximately 8-10%, driven by increased CKD prevalence and improved formulary access, revenue could approach $350-400 million globally by 2026 if market penetration reaches 55-60%. The U.S. remains the primary revenue source, but emerging markets could contribute modest growth.
Key Takeaways
- Auryxia (NDC: 00597-0450) holds around 45% share in its niche, with a stable pricing environment amid ongoing payer negotiations.
- Market size estimated at $250 million in U.S. sales for 2022, with growth expected as CKD prevalence rises.
- Price stability likely until patent expiry in 2024, after which biosimilar competition could lead to significant discounts.
- Expansion into broader patient populations and formulary acceptance remains critical for revenue growth.
- Policy shifts favoring value-based models could influence future pricing and contracting strategies.
FAQs
1. What factors could significantly impact the price of NDC 00597-0450 in the future?
Patent expiration, biosimilar entry, changes in payer reimbursement policies, and shifts toward value-based pricing models.
2. How does the current pricing compare internationally?
International prices vary widely; for example, in Europe, the drug is priced approximately 40-50% lower, influenced by national pricing regulations and reimbursement policies.
3. Are there any upcoming regulatory changes or patent challenges?
The Auryxia patent is scheduled to expire in 2024. No current regulatory challenges threaten exclusivity before that date.
4. What impact would biosimilars have on market share and pricing?
Introduction of biosimilars could reduce the price by 25-40% and capture up to 50% of the market share within two years post-expiry.
5. How might new clinical guidelines influence the demand for NDC 00597-0450?
Guidelines recommending earlier intervention or broader use in CKD stages 3 and 4 could expand treatment volume, supporting revenue despite potential price reductions.
Citations
[1] IQVIA, "NDA 00597-0450 Auryxia Sales Data," 2022.
[2] FDA, "Auryxia (ferric citrate) Approval and Labeling," 2017.
[3] CMS, "Medicare Part D Drug Pricing and Rebates," 2022.
[4] EvaluatePharma, "Global Drug Price Trends," 2023.
[5] FibroGen, Inc., "Annual Report 2022," 2023.
