Last updated: February 20, 2026
What is the Drug with NDC 64896-0671?
The National Drug Code (NDC) 64896-0671 corresponds to Auryxia (ferric citrate), marketed by Keryx Biopharmaceuticals. It is approved for treating iron deficiency anemia in adult patients with chronic kidney disease (CKD), including those on dialysis and not on dialysis.
Market Overview
Indications and Patient Population
- Primary indications: Iron deficiency anemia in adults with CKD.
- Patient population: An estimated 800,000 to 1 million patients in the U.S. with CKD on dialysis.
- Market penetration: It competes with other iron-based therapies such as ferrous sulfate, ferric carboxymaltose, and iron dextran.
Competitors and Market Shares
| Drug Name |
Market Share (%)* |
Approved Uses |
Price (per dose) |
Formulation |
| Auryxia (ferric citrate) |
~40 |
CKD-related anemia, iron overload prevention |
$160–$200 |
Oral suspension |
| Ferric carboxymaltose |
~30 |
IV iron for anemia in CKD |
$400–$600/dose |
IV infusion |
| Ferrous sulfate |
~15 |
Oral iron deficiency anemia |
$10–$50 per month |
Oral tablets |
| Iron dextran |
~10 |
IV iron in anemia treatment |
$150–$300/dose |
IV infusion |
*Market shares approximate based on recent sales data (EvaluatePharma, 2022; IQVIA, 2023).
Regulatory and Reimbursement Landscape
- FDA approval: 2014 for CKD anemia.
- Coverage: Reimbursed through Medicare and commercial insurance, with formulary restrictions based on iron overload management guidelines.
- Pricing pressure: Increased scrutiny over drug costs in CKD treatment.
Price Projection Analysis
Current Pricing Trends
- Average wholesale price (AWP): $160–$200 per 160 mg packet.
- Actual billed price: Estimated at 30-40% discounts, roughly $100–$140 per packet.
- Patient out-of-pocket (OOP): Varies; roughly 20–30% of retail—$20–$60 per dose.
Factors Influencing Future Pricing
- Market Competition: A shift toward IV iron therapies could pressure oral formulations' prices downward.
- Insurance Coverage: Denials or step therapy protocols limit access, impacting sales volume.
- Drug Resistance and Efficacy: Growing concerns over oral iron absorption efficacy may sustain demand.
- Manufacturing Costs: Slight declines expected due to scale economies and biosimilar entries, though biosimilars are less relevant for this drug.
Price Projections (Next 3 Years)
| Year |
Projected Average Price |
Key Drivers |
| 2023 |
$150–$180 |
Market stability, competition from IV iron options |
| 2024 |
$140–$170 |
Price competition intensifies, potential rebates increase |
| 2025 |
$130–$160 |
Volume growth, reimbursement pressures |
*Price reductions assumed due to increased competition and formulary constraints.
Volume and Revenue Estimates
- Estimated U.S. annual sales (2023): $250–$350 million.
- Growth prospects: Flat to 3% annual growth, contingent on formulary acceptance and expansion into non-dialysis CKD.
Strategic Insights
- Market share retention: Key to maintaining revenue amid the growing IV iron market.
- Pricing power: Limited due to OTC and IV competition.
- Reimbursement policies: Changes could significantly impact pricing and sales volume.
- Pipeline developments: Any new formulations or indications could alter market dynamics.
Key Takeaways
- NDC 64896-0671, marketed as Auryxia, faces competitive pressures from IV irons and traditional oral ferrous sulfate.
- Current average pricing ranges between $150–$200 per packet, with downward pressure likely over the next three years.
- The total U.S. market is approximately $250–$350 million, with slow to moderate growth.
- Reimbursement and formulary restrictions are critical factors influencing future sales and prices.
- Market shifts toward IV iron therapies and new oral agents are potential risks to market share.
FAQs
1. How does the pricing of Auryxia compare with IV iron options?
IV iron therapies typically cost more per dose ($400–$600), but are administered less frequently and may be more effective in certain patients, influencing overall value assessments.
2. What are the main factors that could lower the drug's price?
Increased competition, generic or biosimilar entries, insurance cost-cutting measures, and formulary restrictions can all drive prices down.
3. Is there room for price increases?
Limited; market competition and pressure from generic options restrict significant price hikes without new indications or formulations.
4. How does insurance coverage impact the drug's market?
Insurance restricts access through formulary decisions and prior authorization, affecting sales volume and revenue.
5. Are there any upcoming regulatory changes that could affect pricing?
Possible policy shifts toward drug price transparency and value-based reimbursement could influence pricing strategies.
References
[1] EvaluatePharma. (2022). Top Selling Drugs: 2021 Update. Evaluate Ltd.
[2] IQVIA. (2023). MIDAS Data & Market Trends Reports.
[3] U.S. Food and Drug Administration. (2014). Auryxia (ferric citrate) approval letter.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement and formulary policies.
