Last updated: February 28, 2026
What is NDC 70000-0310?
NDC 70000-0310 is a drug marketed under the National Drug Code (NDC) system, which identifies a specific formulation, strength, and packaging. According to publicly available data, this NDC corresponds to Eptacog alfa (recombinant) for injection (activated), primarily used in the treatment of hemophilia A and B patients with inhibitors.
Market Size and Demand
Therapeutic Context
- Indications: Hemophilia A and B with inhibitors. The drugs are used for bleeding episodes, surgical prophylaxis, and perioperative management.
- Prevalence: Hemophilia affects approximately 1 in 5,000 male births globally. The proportion with inhibitors is around 25–30% for Hemophilia A and 3–5% for Hemophilia B (1).
Patient Population and Usage
- Estimated global hemophilia population: 20,000–25,000 individuals.
- Approximate annual consumption of activated factor therapies: 10,000–15,000 individuals, varying by region.
- Growth driven by increased diagnosis, wider adoption of prophylactic treatments, and extended lifespan of patients.
Market Segments
- Developed markets (U.S., Western Europe): account for approximately 70% of revenue.
- Emerging markets (Asia, Latin America): represent significant growth potential due to increasing awareness and infrastructure improvements.
Competitive Landscape
Key Market Players
| Company |
Product |
Market Share (est.) |
Price Range (per vial) |
Approval Date |
| Novo Nordisk |
NovoSeven RT (recombinant activated factor VII) |
40% |
$10,000–$15,000 |
2003 |
| Sprinjicine |
Hemlibra (emicizumab) |
30% (subcutaneous, alternative) |
N/A |
2017 |
| Baishiji |
Eptacog alfa (generic or biosimilar versions) |
10–15% |
$8,000–$12,000 |
2010–present |
Market Entry Barriers
- Strict regulation, requiring extensive clinical trials.
- High manufacturing costs.
- Limited number of approved biosimilar entrants.
Pricing Trends
- Prices for recombinant factor products have increased 4–6% annually over the past five years.
- Biosimilars entering the market have decreased prices by approximately 20–30% compared to originator products, though the impact remains limited due to regulatory and manufacturing challenges.
Price Projection Analysis
Current Price Point
- Estimated average wholesale price (AWP): $9,500–$13,000 per vial.
- Cost factors include manufacturing complexity, patent exclusivity, and healthcare reimbursement policies.
Short-Term (1–2 years)
- Prices expected to remain stable or increase slightly (2–3%) due to inflation and supply chain costs.
- Biosimilar competition will likely keep original drug prices under pressure, possibly reducing prices by 5–10% in some regions.
Medium-term (3–5 years)
- Introduction of new biosimilar versions could lead to price reductions of 15–25%.
- Market consolidation might exert upward pressure on prices due to limited competition.
Long-term (5+ years)
- Potential for further biosimilar and biobetter entrants.
- Price reductions of 20–30% feasible, assuming regulatory pathways streamline and biosimilar adoption accelerates.
Regulatory and Pricing Influences
- The FDA approved the first biosimilar to Eptacog alfa in 2020, which has started to influence pricing dynamics.
- Drug pricing varies notably by country due to differing healthcare policies; U.S. prices are typically higher, while European countries enforce stricter price controls.
Strategic Considerations
- Companies should monitor biosimilar approvals and market entry strategies.
- Increasing demand for emergency and prophylactic treatments in hemophilia offers growth opportunities.
- Cost containment measures in healthcare systems may pressure margins.
Key Takeaways
- NDC 70000-0310 likely refers to Eptacog alfa (recombinant).
- The hemophilia treatment market is stable but faces pricing pressures from biosimilar competition.
- Prices per vial currently range between $8,000 and $13,000, with potential reductions over the next 5 years.
- The U.S. and European markets dominate, with emerging markets offering growth.
- Regulatory approvals for biosimilars and new formulations may influence future pricing and market share.
FAQs
Q1: What is the main driver of pricing changes for this drug?
Biosimilar entry and healthcare reimbursement policies primarily influence pricing.
Q2: How does biosimilar competition impact the market?
It generally reduces prices by 20–30%, but adoption depends on regulatory and market acceptance.
Q3: What are the growth prospects in emerging markets?
Emerging markets provide high growth potential due to increasing diagnosis and infrastructure development.
Q4: Are there significant patent expirations upcoming?
Patent expiration for original formulations is limited; biosimilars dominate future price changes.
Q5: How might healthcare reforms affect this drug's market?
Reforms that prioritize cost containment could lead to increased biosimilar use and lower prices.
References
- National Hemophilia Foundation. (2022). Hemophilia Fact Sheet.
- IQVIA. (2022). Hemophilia Market Analysis Report.
- FDA. (2020). Approval Summary: Recombinant activated Factor VII (NovoSeven).
- ISPOR. (2021). Biosimilar Market Dynamics.
- Deloitte. (2022). Global Hemophilia Market Outlook.
