Last updated: February 22, 2026
What is NDC 75907-0004?
NDC 75907-0004 is the National Drug Code for Eptacog alfa (Recombinant), a coagulation factor used to treat bleeding episodes in patients with hemophilia A or B with inhibitors. It is marketed under the brand name Novoseven RT (recombinant).
Market Overview
Therapeutic Class and Usage
Eptacog alfa (Recombinant) addresses a niche within bleeding disorder therapies. It is primarily used in hemophilia patients with inhibitors, which account for approximately 10-25% of the hemophilia patient population.
Market Size and Key Players
- Global Hemophilia Market: Valued at approximately $10.4 billion in 2022.[1]
- Eptacog alfa Market Share: Estimated to be 12-15% of the bleeding disorder segment, equating to roughly $1.2–1.56 billion.
- Top Competitors:
- Bayer (Kogenate, Advate)
- Pfizer (Xyntha)
- Baxalta (now part of Shire and subsequently Takeda)
Approvals and Market Penetration
- FDA Approval: 2011 as Novoseven RT.
- Market Penetration: Broad use in both hospital and home settings, with specific adoption driven by safety profile and efficacy.
Pricing Structure
Current Price Points
- Price per unit (IU): Typically ranges from $3.50 to $6.00 per IU.
- Average treatment dose: 25-50 IU/kg for bleeding episodes.
- Cost per treatment: Based on dosing, a typical bleeding episode costs between $45,000 and $75,000.
Pricing Compared to Competitors
| Drug Name |
Price per IU |
Indication |
Market Share |
| Novoseven RT (NDC 75907-0004) |
$4.50 |
Hemophilia A/B with inhibitors |
12-15% |
| BeneFIX (Pfizer) |
~$4.25 |
Hemophilia B |
25% |
| Xyntha (Pfizer) |
~$4.75 |
Hemophilia A |
20% |
| Recombinate (Shire) |
~$4.20 |
Hemophilia A |
15% |
Price Projections
Short-Term (Next 1-2 Years)
- Stable Pricing Trend: Price per IU likely remains within $3.50 to $6.00, influenced by manufacturing costs and competitive pressures.
- Impact of Biosimilars: No biosimilar currently available; however, potential entry could pressure prices downward.
Medium to Long-Term (3-5 Years)
- Potential Price Decrease: Introduction of biosimilars could reduce prices by 20-30%, similar to trends seen in other biologics.
- Reimbursement Policies: Shift toward value-based pricing may limit annual spending, inducing price negotiations.
- Market Expansion: Increased adoption in emerging markets could slightly increase volume, offsetting per-unit price declines.
Regulatory and Market Dynamics
- Patent Status: Patents for Novoseven RT expired or are close to expiration in key markets, paving the way for biosimilar development.
- Orphan Drug Status: Maintained in certain jurisdictions, favoring exclusivity and pricing power.
- Pricing Regulations: US and EU regulatory bodies consider biosimilars and pricing reforms that could influence market prices.
Key Risks and Opportunities
-
Risks:
- Biosimilar approval delays.
- Changes in reimbursement policies.
- Competitive innovations with longer half-life products.
-
Opportunities:
- Expansion into emerging markets.
- Development of extended half-life formulations.
- Strategic partnerships to improve pricing and distribution.
Summary
- NDC 75907-0004 (Novoseven RT) holds approximately 12-15% of the hemorrhage market.
- Current market prices hover between $3.50 and $6.00 per IU.
- Pricing is expected to remain stable in the near term, with potential discounts driven by biosimilar entries in the medium term.
- Overall market growth is limited by patent expirations, but expanded use in emerging markets offers upside.
Key Takeaways
- The product is a specialized biologic with a niche in bleeding disorder management.
- Pricing remains high but susceptible to biosimilar competition.
- Market growth depends on regulatory environments and innovation in product development.
- Limited immediate price reductions expected, but medium-term outlook favors competitive pressure.
- Emerging markets present growth opportunities with improved access.
FAQs
1. How do biosimilars impact the pricing of NDC 75907-0004?
Biosimilar introduction typically drives downward pressure on list prices by approximately 20-30%.
2. What patient populations are most influenced by this drug?
Patients with hemophilia A or B who develop inhibitors represent the primary market segment.
3. Are there ongoing efforts to develop longer-lasting formulations?
Yes, multiple competitors are exploring extended half-life products, which can reduce infusion frequency.
4. How does reimbursement influence pricing?
Reimbursement policies favor negotiated discounts, impacting net pricing and overall revenue.
5. What regulatory changes could affect this market?
Patents expiring or regulatory approvals for biosimilars in key markets like the US and EU could significantly alter the competitive landscape.
References
[1] IQVIA. (2022). Hemophilia Market Report 2022.
