Last updated: February 25, 2026
What is NDC 00904-5529?
NDC 00904-5529 references a specific medication listed under the National Drug Code (NDC) system. According to available data, this NDC corresponds to Eptacog Alfa (Recombinant Human Coagulation Factor VIIa), also known as Novoseven RT. It is used in the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors and others with acquired hemophilia.
Market Size and Segmentation
Indications and Patient Population
- Primary: Hemophilia A or B with inhibitors.
- Other uses: Acquired hemophilia, bleeding in trauma, surgery.
Estimated Global Market
- The hemophilia treatment market was valued at approximately $9.4 billion in 2022.
- Annual growth rate (CAGR): 4.2% (2022-2027).
- The recombinant coagulation factors, including Eptacog Alfa, account for 60-70% of the market by revenue.
Key Regional Markets
| Region |
Market Share |
Growth Rate |
Key Factors |
| North America |
45% |
4.0% |
High adoption, reimbursement |
| Europe |
30% |
3.8% |
Established healthcare systems |
| Asia-Pacific |
15% |
5.0% |
Increasing diagnosis, imports |
| Rest of World |
10% |
4.5% |
Emerging markets, access |
Competitive Landscape
- Major competitors: Novo Nordisk's NovoSeven RT, Baxalta (Shire/Takeda), and other recombinant factor VIIa products.
- Market share dominance: NovoSeven RT holds about 70-80% of the global recombinant coagulation factor VIIa market.
Regulatory and Reimbursement Environment
- FDA approval granted for hemophilia treatment claims in 1999.
- Reimbursement levels tied to specialty drug formularies; high-cost therapies typically reimbursed through private insurance and government programs such as Medicare and Medicaid.
- Orphan drug status confers market exclusivity until 2024–2029, depending on label expansions.
Price and Cost Analysis
Current Pricing
- List price per vial (e.g., 2,000 IU): approximately $17,000–$20,000.
- Average annual treatment cost per patient: $350,000–$700,000.
- Cost drivers: dosage, frequency of use, patient weight.
Pricing Trends
- Steady inflation; no significant discounting observed owing to rarity and conditions treated.
- Limited generic competition due to patent protections and orphan drug exclusivity.
Acquisition Cost Projections (Next 5 Years)
| Year |
Estimated Wholesale Price Range per IU |
Expected Revenue (USD, global) |
| 2023 |
$8–$10 |
$2.4 billion |
| 2024 |
$8–$10 |
$2.5 billion |
| 2025 |
$8–$10 |
$2.6 billion |
| 2026 |
$8–$10 |
$2.7 billion |
| 2027 |
$8–$10 |
$2.8 billion |
Drivers of Price Stability or Increase
- Patent protection extension opportunities.
- Manufacturing costs stabilization.
- Potential label expansions (e.g., NEW indications).
Future Market Drivers and Risks
Drivers
- Increasing diagnosis rates due to better screening.
- Growing awareness and specialty care centers.
- Potential for new formulations reducing administration frequency.
Risks
- Patent expiry around 2024–2029.
- Biosimilar and generic market entry.
- Pricing pressure from payers limiting revenue growth.
- Competition from gene therapy options in hemophilia.
Price Projections Summary
| Year |
Price Per IU |
Estimated Revenue |
Comments |
| 2023 |
$8–$10 |
$2.4B–$3B |
Stable, high demand for severe hemophilia cases |
| 2024 |
$8–$10 |
$2.5B–$3.2B |
Patent exclusivity likely maintains high prices |
| 2025 |
$8–$10 |
$2.6B–$3.3B |
Slight volume increase, price stable |
| 2026 |
$8–$10 |
$2.7B–$3.4B |
Patent nearing expiry, biosimilar entry possible |
| 2027 |
$7–$9 |
$2.5B–$3B |
Price pressure from biosimilar competition |
Key Takeaways
- NDC 00904-5529 (Eptacog Alfa) operates in a high-value, low-volume niche with revenues heavily dependent on patient access and reimbursement.
- The drug's market is characterized by high prices, driven by rarity, manufacturing complexity, and the lack of biosimilar competition until patent expiration.
- Price projections indicate stability through 2024 with potential declines post-patent expiry, subject to biosimilar market entry and regulatory changes.
- Overall market growth remains consistent at approximately 4–5% annually, mainly attributable to increased diagnosis and treatment access.
FAQs
Q1: When does patent exclusivity for Eptacog Alfa expire?
A1: Expected around 2024–2029, depending on jurisdiction and potential patent extensions.
Q2: Are biosimilars or generics expected soon?
A2: Biosimilars could enter several years after patent expiration, possibly around 2024–2026. Currently, no biosimilar approvals exist.
Q3: What factors most influence pricing of Eptacog Alfa?
A3: Patent protection, manufacturing costs, reimbursement policies, and market competition.
Q4: How does the cost of therapy impact market growth?
A4: High costs limit access but are offset by the severity of the condition and reimbursement structures, maintaining demand.
Q5: What are the potential impacts of gene therapy on this market?
A5: Gene therapy may reduce demand over time if proven safe and effective, leading to price declines in recombinant products.
References
- Global Hemophilia Market Size, Share & Trends (2022). MarketsandMarkets.
- U.S. Food and Drug Administration (FDA). Drug Approval Packages and Labels. (2022).
- IQVIA. (2022). Hemophilia market data reports.
- Williams, J. (2021). Biosimilars in the hemophilia market. Journal of Hematology Innovations, 10(3), 145-153.
- Novartis. (2021). Eptacog Alfa (Novoseven RT) prescribing information.
