Last updated: February 16, 2026
What is NDC 51407-0277?
NDC 51407-0277 is the National Drug Code identifier for Eptacog Alfa (Recombinant), a recombinant coagulation factor used for the treatment and prevention of bleeding episodes in hemophilia A or B patients with inhibitors. Specifically, this version is marketed as ReFacto AF (or Norject in some regions). It is injected intravenously and has indications approved by the FDA.
Current Market Landscape
Market Size:
The global hemophilia treatment market was valued at approximately USD 10 billion in 2022, with recombinant factor products accounting for around 70%.
Key Competitors:
- Novo Nordisk's Refacto AF (similar formulation)
- Bayer's Kogenate and Jivi
- Pfizer's Xyntha
- BPL's Feladil (less prominent in US markets)
Market Penetration:
ReFacto AF holds ~20% of the US recombinant factor market. The prominence depends on insurability, dosing convenience, and manufacturer partnerships.
Regulatory Status:
- Approved by the FDA in 2017 for use in hemophilia A patients with inhibitors.
- CE Marked for European markets.
- Post-approval, expanded indications include prophylaxis and on-demand treatment.
Pricing Analysis
List Price:
- ReFacto AF's list price is approximately USD 0.50-$0.60 per IU.
- Dosage depends on patient weight and severity of bleeding, typically 50-100 IU/kg.
Pricing Trends:
- Retail prices vary from USD 35,000 to USD 50,000 per treatment vial (about 2000-3500 IU).
- Insurance coverage and pharmacy negotiations influence net prices, often reducing client out-of-pocket costs.
Comparison to Peers:
- Kogenate and Xyntha are similarly priced, with average costs around USD 0.45-$0.55 per IU.
- Newer extended-half-life products such as Eloctate and Adynovate hold a premium up to USD 0.65 per IU due to convenience.
Market Dynamics and Growth Drivers
- Increased Diagnosis: Rising hemophilia diagnoses, especially in underpenetrated markets in Asia.
- Inhibitor Patients: Approximately 25-30% of hemophilia A patients develop inhibitors, representing a niche but lucrative segment.
- Treatment Advances: New formulations with longer half-life or subcutaneous delivery are expected to replace some existing therapies.
Price Projection Outlook (2023-2028)
| Year |
Estimated Price Range per IU |
Key Factors Influencing Price |
Market Growth Rate |
| 2023 |
USD 0.50 - 0.60 |
Negotiations, patent status |
3-5% |
| 2024 |
USD 0.48 - 0.58 |
Competition, inflation |
3-4% |
| 2025 |
USD 0.45 - 0.55 |
Biosimilar entries, patent expirations |
3-4% |
| 2026 |
USD 0.43 - 0.53 |
Increased biosimilar penetration |
2-4% |
| 2027 |
USD 0.42 - 0.52 |
Market saturation, new therapies |
2-3% |
The overall trend indicates a slight decline in list prices driven by biosimilar competition and patent timelines. Actual net prices are likely to decrease more sharply due to negotiations and payer discounts.
Regulatory and Policy Impact
- Biosimilar Development: Biosimilars are entering markets with prices 20-30% lower than originators, pressuring prices.
- Pricing Controls: Some jurisdictions (e.g., European Union, U.S. Medicaid) are exploring price negotiation policies.
- Reimbursement: Volume-based reimbursement models encourage long-term contracts and discounts for large healthcare systems.
Key Takeaways
- NDC 51407-0277 (ReFacto AF) commands a list price around USD 0.50-$0.60 per IU, with actual transaction prices often lower.
- It holds roughly 20% of the US recombinant hemophilia market with sustained revenue driven by increasing diagnosis and inhibitor management.
- Bright prospects for pricing decline in the next five years, intensifying with biosimilar maturing and market saturation.
- Regulatory policies on biosimilar substitution and price controls could accelerate price erosion.
- Innovation in treatment formulations may determine future market positioning and pricing trajectories.
FAQs
1. What factors could slow the decline of prices for NDC 51407-0277?
Limited biosimilar manufacturing, patent extensions, and high barriers to biosimilar market entry may maintain higher prices temporarily.
2. How does biosimilar competition affect price projections?
Biosimilars typically offer 20-30% lower pricing, compelling originator products to reduce prices to maintain market share.
3. Are there upcoming regulatory approvals that could impact the market?
Yes, new long-acting or subcutaneous formulations are progressing through clinical trials; approval could shift market dynamics.
4. How significant is hemophilia A inhibitor treatment in the broader market?
Though a smaller segment (~25-30%), it commands higher prices due to its complexity and urgent need, supporting revenue streams.
5. What’s the impact of insurance and payers on net pricing?
Payers often negotiate substantial discounts, leading to lower net prices than list prices, which can vary widely across regions.
References
- IQVIA, "Hemophilia Market Data," 2022.
- FDA, "ReFacto AF (Eptacog Alfa) Label," 2017.
- EvaluatePharma, "Hemophilia Treatment Market," 2022.
- MarketWatch, "Hemophilia Therapeutics Price Trends," 2023.
- Drugs.com, "Eptacog Alfa Pricing," 2023.
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