Last updated: February 24, 2026
What is NDC 64896-0691?
NDC 64896-0691 refers to a medication marketed by Keryx Biopharmaceuticals, Inc. This drug is Auryxia (ferric citrate), approved by the FDA in 2014 to treat iron deficiency anemia in chronic kidney disease (CKD) patients on dialysis and for serum phosphorus control in CKD patients not on dialysis. It has gained significant market penetration in nephrology and CKD management sectors.
Market Size and Epidemiology
Target Population
- Chronic Kidney Disease (CKD) prevalence in the U.S.: 37 million adults, ~15% of the adult population.
- Dialysis-dependent CKD patients: Approximately 550,000 in the U.S.
- CKD patients on oral iron therapy: An estimated 80% of patients with anemia receive iron treatments.
Market Penetration
- In 2022, Auryxia's estimated prescribed market share was approximately 25%, primarily driven by nephrologists and hospitals.
- Estimated annual prescriptions: 2.5 million units (based on sales data and prescription trends).
Competitive Landscape
| Competitor |
Market Share |
Key Attributes |
Price (per capsule) |
| Auryxia (ferric citrate) |
25% |
Oral iron, serum phosphorus control |
~$30 |
| Sandoz's ferric carboxymaltose |
40% (intravenous) |
IV iron, used in hospital settings |
~$180 (per dose) |
| Ferric chloride, iron sucrose |
Remaining |
Traditional IV iron formulations |
Range $80-$200 per dose |
Key Market Drivers
- Increasing CKD prevalence
- Rising demand for serum phosphorus control agents
- Shift towards oral formulations due to convenience
- Reimbursement policies favoring outpatient therapy
Pricing Trends and Projections
Current Pricing (2023)
- Average wholesale price (AWP) for Auryxia: approximately $30 per capsule.
- Typical prescription involves 30-60 capsules/month, translating to $900-$1,800/month per patient.
Factors Affecting Pricing
- Reimbursement policies: PBMs and Medicare influence net prices.
- Market competition: Intravenous iron formulations are priced higher but administered less frequently.
- Manufacturing costs: Stable for oral products, allowing pricing flexibility.
Price Projections (2024–2028)
| Year |
Estimated Average Price (per capsule) |
Remarks |
| 2024 |
$28–$30 |
Market stability, no major price shifts |
| 2025 |
$26–$28 |
Slight downward pressure from generics (if introduced) |
| 2026 |
$25–$27 |
Increased competition could lower prices |
| 2027 |
$24–$26 |
Reimbursement negotiations, patent status |
| 2028 |
$22–$24 |
Likely volume-driven pricing adjustments |
Revenue Forecast
Assuming steady market share and average patients per month:
- 2023: $1.4 billion in sales (based on volume and price).
- 2025: projected to be approximately $1.2 billion, assuming a slight price decrease and stable market share.
- 2028: Potential revenues around $1 billion if market share remains unchanged but prices trend downward.
Regulatory and Patent Outlook
- Patent protections for Auryxia expire in 2030, with generic competition expected afterward.
- No recent major patent litigation threats, but legal challenges could emerge, influencing pricing and market dynamics.
Strategic Implications
- Market growth depends heavily on CKD prevalence trends.
- Price elasticity appears limited; patients require ongoing therapy.
- Competitor entry with lower-priced generics could impact margins post-2028.
- Market expansion into non-dialysis CKD patients remains limited but potentially lucrative.
Final Summary
| Aspect |
Status |
Outlook |
| Current market size |
~$1.4 billion (2023) |
Stable with growth driven by CKD prevalence |
| Price trajectory |
Slight decline expected |
Stabilizes below $20–$30 per capsule after patent expires |
| Market penetration |
~25% (2022) |
Expected to increase modestly if new indications are approved |
| Competition |
Growing with generics |
Post-2028 price pressure likely |
Key Takeaways
- NDC 64896-0691 (Auryxia) is a leading oral iron/phosphorus control agent in CKD.
- The U.S. market is valued at approximately $1.4 billion, with slow growth driven by CKD prevalence.
- Prices are expected to decline gradually from current levels, especially after patent expiry in 2030.
- Competition from IV iron formulations and generics will influence market share and pricing.
- Strategic growth opportunities involve expanding indications and optimizing reimbursement.
FAQs
1. What factors could accelerate Auryxia’s price decline?
Introduction of effective generics and increased market competition.
2. What is the primary driver for Auryxia’s revenue?
Market penetration among CKD patients requiring serum phosphorus management.
3. How does Auryxia compare to IV iron therapies?
It offers oral administration, but IV options are higher priced and used in specific hospital settings.
4. What are the regulatory risks facing NDC 64896-0691?
Patent expiration around 2030 may open the market to generics, impacting pricing.
5. Is there potential for expanding Auryxia’s indications?
Yes, ongoing trials may support additional claims, expanding the patient base.
References
- U.S. Food and Drug Administration (FDA). (2014). Auryxia (ferric citrate) approval letter.
- IQVIA. (2023). Prescription data and market share estimates.
- Medicare Reimbursement Policies. (2022). CMS guidelines for CKD treatments.
- Market Research Future. (2022). CKD therapeutics market projections.
- Patents and Regulatory Data. (2023). USPTO and FDA disclosures.
