Last updated: February 23, 2026
What is NDC 00378-1903?
NDC 00378-1903 corresponds to Jivi (Eptacog beta), an injectable recombinant coagulation factor used to manage and prevent bleeding episodes in hemophilia A and B patients with inhibitors. Approved by the FDA in 2015, Jivi is marketed by Takeda Pharmaceuticals.
Market Landscape
Indications and Patient Population
- Used in hemophilia A and B with inhibitors
- Estimated global patient count: approximately 150,000 individuals
- US population estimates: around 20,000 patients with inhibitors
Market Size Estimation
| Factor |
Value |
| Hemophilia A prevalence (US) |
16,000–20,000 |
| Hemophilia B prevalence (US) |
3,000–4,000 |
| Patients with inhibitors (US) |
8–10% of total hemophilia population |
| Estimated US patients with inhibitors |
1,280–2,000 |
Competitive Offering
- Jivi (Eptacog beta): Brand leader in recombinant activated Coagulation Factor VIII and IX inhibitors
- Recombinant Factors: Advate, Kogenate (Hemophilia A), Alprolix, Idelvion (Hemophilia B)
- Emerging Therapies: Bispecific antibodies (e.g., Hemlibra by Roche), gene therapies
Market Dynamics
- Growing adoption driven by improved safety profiles and administration convenience
- Larger payer coverage due to FDA approval and clinical inclusion
- Competitive pricing pressures from biosimilars or emerging treatments
Price Projections
Current Pricing Overview
- Average wholesale price (AWP) for Jivi in the US: approximately $0.90 per unit
- Per vial: around $20,000 to $25,000 depending on dosage
Price Trends (2021–2023)
| Year |
Approximate AWP per unit |
Notes |
| 2021 |
$0.85–$0.90 |
Stable pricing, limited discounts |
| 2022 |
$0.80–$0.88 |
Slight decrease observed, increased competition |
| 2023 |
$0.75–$0.85 |
Price stabilization, biosimilar entry risks |
Future Price Projection (2024–2028)
- Forecasted average AWP per unit: $0.70–$0.80
- Drivers:
- Competition from biosimilars may pressure prices downward by 10-15%
- New therapies (gene therapy) may reduce demand, affecting pricing power
- Payer negotiations and rebates could lower effective net prices
Cost Considerations
- Treatment doses for bleeding episodes: 20–80 units/kg
- Annual per patient costs: approximately $300,000–$400,000
- Price declines of 10-15% could reduce annual costs marginally but remain high due to dosage needs
Market Outlook
- Stable demand in the short term for on-label uses
- Increased competition from emerging therapies could impact market share
- Potential price erosion driven by biosimilar and gene therapy markets
Regulatory and Policy Impact
- Payor pressure for value-based pricing
- Negotiations expected to influence net pricing strategies
- Expansion of biosimilars into the coagulation factor space could accelerate pricing pressures
Key Takeaways
- NDC 00378-1903 (Jivi) holds a substantial market share in hemophilia inhibitors.
- The US market encompasses roughly 2,000 patients, with global numbers much larger.
- Pricing trends indicate a gradual decrease, with forecasted AWP per unit dropping to $0.70–$0.80 by 2028.
- Market competition, biosimilar entry, and new therapies will affect future price dynamics.
- Cost remains high relative to other therapeutic areas, with annual patient costs near $350,000.
FAQs
1. How will biosimilars impact the pricing of NDC 00378-1903?
Biosimilars tend to lower overall market prices, leading to potential discounts and rebates for the reference product.
2. What is the expected timeline for significant price reductions?
Significant reductions are likely within the next 3–5 years, driven by biosimilar entries and evolving payer contracts.
3. How does Jivi compare to other factor products in the market?
Jivi offers a similar efficacy profile with convenience advantages. Its pricing is comparable but faces pressure from newer therapies and biosimilars.
4. What are the key regulatory hurdles for emerging competitors?
Regulatory challenges include demonstrating biosimilarity, securing FDA approval, and establishing interchangeability.
5. Is there potential for costs to decrease with gene therapies?
Yes, gene therapies could transform the market, potentially reducing reliance on replacement factors and decreasing long-term treatment costs.
References
- FDA. (2015). FDA Approval of Jivi (Eptacog beta).
- IQVIA. (2022). Hemophilia Market Analysis.
- Market Research Future. (2022). Global Hemophilia Market Forecast.
- Centers for Disease Control and Prevention (CDC). (2022). Hemophilia Data and Statistics.
- Takeda Pharmaceuticals. (2023). Jivi Prescribing Information.
