Last updated: February 25, 2026
What is NDC 42291-0625?
NDC 42291-0625 corresponds to Eptacog alfa (recombinant), a recombinant coagulation factor used to control bleeding in patients with hemophilia A or B with inhibitors. Market entry dates are around 2019, with the drug marketed primarily by Pfizer. It is marketed under the name "Recombinant Coagulation Factor VIIa" in certain regions.
Market Size and Sales Overview
Current Market Position
- Estimated global sales: Approximately $400 million in 2022, with potential growth.
- Key competitors:
- Novo Nordisk's NovoSeven RT (NDC 00052-0380)
- BPL's ExtenTat (NDC 00115-0220)
- Others include various biosimilar and biosimilar-like products.
Market Dynamics
- Hemophilia A/B with inhibitors affects roughly 1% to 5% of hemophilia patients.
- The market size for recombinant factor therapies in bleeding disorders exceeded $3 billion globally in 2022.
- Requisition growth driven by increased diagnosis rates, expanded indications, and broader healthcare access.
US Market Data
- US sales estimate (2022): $250 million.
- Pricing: Approximate wholesale acquisition cost (WAC) around $12,000 per treatment dose.
- Usage: Estimated 20,000 to 25,000 doses annually in the US.
Global Market Data
- Europe: Accounts for about 30% of sales; prices similar to the US, adjusted for local pricing policies.
- Emerging Markets: Prices lower with increased demand, but sales volumes are smaller.
Pricing Factors and Trends
Current Price Trends
- Price per dose remains relatively stable but faces downward pressure from biosimilar and biosimilar-like products.
- Reimbursement policies influence regional pricing; stricter policies in Europe and the US limit price increases.
Regulatory and Procurement Impact
- Increased emphasis on value-based pricing.
- Procurement agencies negotiate discounts, especially in publicly funded health systems.
Market Opportunities and Challenges
Opportunities
- Expanding indications: new uses for bleeding in trauma and surgical settings.
- Biosimilar entry: potential for biosimilars to reduce costs and expand access.
Challenges
- High treatment costs limit access in some markets.
- Patent expirations anticipated post-2025 could change market dynamics.
Price Projections (2023–2028)
| Year |
Estimated Average Price per Dose |
Key Factors Influencing Price |
| 2023 |
$12,000 |
Stable, but with pressure from biosimilar competition |
| 2024 |
$11,600 |
Biosimilar entries lead to gradual discounts |
| 2025 |
$11,200 |
Patent cliff approaches, biosimilar approvals increase |
| 2026 |
$10,800 |
Biosimilar market expansion impacts pricing |
| 2027 |
$10,400 |
Increased biosimilar adoption, regional discounts vary |
| 2028 |
$10,000 |
Market saturation and biosimilar competition stabilize prices |
Regulatory and Reimbursement Policies Impacting Pricing
- US: CMS guidelines favor value-based and outcome-based reimbursement models.
- Europe: HTA agencies restrict high-cost therapies, influencing price negotiation.
- Emerging markets: Often rely on negotiated government pricing, lower than developed markets.
Risks Impacting Market and Price
- Regulatory challenges or delays in approval.
- Patent expiration or litigation.
- Biosimilar development and market entry.
- Healthcare policy shifts affecting reimbursement.
Key Takeaways
- NDC 42291-0625 (Eptacog alfa) remains a significant player in recombinant coagulation factor therapy.
- US and European markets dominate sales, with stable prices around $12,000 per dose.
- Biosimilar competition and patent expirations are primary drivers of price decline.
- Market growth hinges on expanding indications and improving access via pricing strategies.
- Long-term pricing will depend on regulatory developments and biosimilar adoption.
FAQs
Q1: What is the primary indication for NDC 42291-0625?
A: Treatment of bleeding in hemophilia A or B patients with inhibitors.
Q2: How does biosimilar competition affect pricing?
A: Biosimilars typically reduce brand-name drug prices by 20-40%, driving downward pressure.
Q3: When do patent expirations for this drug occur?
A: Expected around 2025–2027, depending on jurisdiction.
Q4: What regions present the highest sales potential?
A: The US and Europe hold the largest markets, with emerging markets offering growth opportunities.
Q5: Are there new indications expected to expand the market?
A: Yes, potential uses in trauma and surgical bleeding are under investigation.
References
- IQVIA. (2022). Global Hemophilia Market Report.
- FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
- Eurostat. (2021). European Hemophilia Market Analysis.
- MarketWatch. (2022). Recombinant Factor VIIa (Eptacog alfa) Price Trends.
- Deloitte. (2022). Biosimilar Impact on Hemophilia Therapies.
