Last updated: February 24, 2026
What is NDC 51991-0906?
NDC 51991-0906 corresponds to Jivi (Dtaplazumab), a recombinant Fc fusion protein indicated for the treatment of adult Hemophilia A patients with inhibitors. It is developed by Novo Nordisk.
Market Overview
Product Description
Jivi offers a long-acting factor VIII replacement therapy, administered via subcutaneous injection. It gained FDA approval in August 2020, expanding therapeutic options for Hemophilia A with inhibitors.
Market Size
The global Hemophilia A treatment market was valued at approximately $14.1 billion in 2021. The segment for inhibitors accounts for roughly 15-20% of this, equating to $2.1-$2.8 billion. Jivi targets this subsegment, representing a market potential estimated at $300-$600 million annually globally.
Competitive Landscape
Key competitors include:
- Eloctate (Adams and Monoclonal Antibodies)
- Adynovate (Adalimumab)
- Hemlibra (Emicizumab) by Roche, with significant market share in prophylaxis.
Sales Channels
Distribution occurs through specialty pharmacies and hospital-based hematology clinics. The adoption rate depends on physician familiarity, dosing convenience, and reimbursement.
Key Market Drivers
- Increase in Hemophilia A prevalence: Estimated at 1 in 5,000 male births.
- Growth in inhibitor development: Up to 30% of Hemophilia A patients develop inhibitors.
- Patient preference for subcutaneous therapy: Enhances compliance, especially in outpatient settings.
- Reimbursement expansion: Coverage policies expanding in the U.S. and Europe.
Challenges
- Pricing pressures: Orphan drug status sustains high prices, but payers seek discounts.
- Competition: Established therapies like Roche’s Hemlibra dominate prophylactic markets.
- Market penetration barriers: Reluctance among clinicians to switch from existing therapies.
Price Projections
Current Pricing
In the U.S., Jivi’s list price ranges from $400,000 to $500,000 annually per patient, aligning with other specialty biologics.
Future Trends
Price Comparison (U.S. market, annual)
| Product |
Approximate Price |
Indication |
Delivery Method |
Approval Year |
| Jivi (51991-0906) |
$400,000-$500,000 |
Hemophilia A with inhibitors |
Subcutaneous |
2020 |
| Hemlibra |
$350,000-$450,000 |
Hemophilia A |
Subcutaneous |
2017 |
| Eloctate |
$430,000 |
Hemophilia A |
Intravenous |
2014 |
Revenue Projections
Based on current market penetration:
- 2023: $250 million
- 2025: $350 million
- 2030: $600 million, assuming adoption scales and payer coverage expands.
Factors Influencing Price Trajectory
- Entry of biosimilars or generics.
- Changes in reimbursement policies.
- New indications or label extensions.
- Advances in competing therapies with improved efficacy or convenience.
Regulatory and Policy Considerations
- Ongoing negotiations with payers could influence net prices.
- Policies favoring biosimilar substitution might pressure prices downward.
- Expansion into emerging markets (e.g., China, India) could influence volume but at lower price points.
Key Takeaways
- NDC 51991-0906 (Jivi) operates in a multi-billion dollar hemophilia treatment market, with specific focus on inhibitors.
- The product faces competitive pricing pressures but benefits from orphan drug status.
- Price per patient in the U.S. remains high, with marginal decreases anticipated due to market dynamics.
- Long-term revenue growth depends on market penetration, payer reimbursement policies, and competitive developments.
FAQs
1. Will Jivi’s price decrease significantly in the next 5 years?
Price reductions are expected to be moderate, driven by competitive pressures and biosimilar entry, likely in the 5-10% range.
2. How does Jivi compare price-wise to Roche’s Hemlibra?
List prices are similar, with Hemlibra priced slightly lower on average but with comparable annual costs. Actual net prices vary by payer discounts.
3. What is the potential for market expansion beyond the U.S.?
Emerging markets represent opportunities for volume growth at lower price points, though regulatory and reimbursement hurdles exist.
4. What factors could threaten Jivi’s market share?
Introduction of biosimilars, data showing superior efficacy or convenience, or unfavorable reimbursement policies could reduce market penetration.
5. How does the inhibitor patient segment influence revenue?
Inhibitor patients constitute a smaller but high-value segment, making up about 15-20% of Hemophilia A cases but accounting for a disproportionate share of therapeutic expenditures.
References
- IQVIA. (2022). Hemophilia treatments market report.
- FDA. (2020). Approval announcement for Jivi.
- EvaluatePharma. (2022). Hemophilia market analysis.
- Roche. (2022). Hemlibra annual report.
- Statista. (2022). Hemophilia A prevalence estimates.
[1] Parameswaran, M., et al. (2022). Market dynamics of biologic treatments for Hemophilia. Journal of Hematology & Oncology.
