Last updated: March 13, 2026
What is the drug associated with NDC 43598-0581?
NDC 43598-0581 is a medication identified as Rebinyn (coagulation factor IX, recombinant), used in the treatment and prevention of bleeding episodes in patients with hemophilia B. It is produced by Novo Nordisk. Rebinyn is a long-acting recombinant factor IX product, approved by the FDA in 2018.
Market Size and Demand Dynamics
Hemophilia B Market Overview
- The global hemophilia B market was valued at approximately USD 3.6 billion in 2022.
- It is projected to reach USD 4.3 billion by 2028, with a compound annual growth rate (CAGR) of roughly 3.2% (Fortune Business Insights).
Key Drivers
- Increased diagnosis rates, driven by improved screening methods.
- Longer life expectancy of patients, leading to sustained treatment demand.
- The entry of extended half-life products like Rebinyn, reducing infusion frequency.
Patient Population
- Estimated at approximately 16,000 patients worldwide.
- The U.S. accounts for nearly 60% of the global patient base.
- Growth potential exists in emerging markets with expanding hemophilia diagnosis rates.
Competitive Landscape
- Major players include Novo Nordisk, Bioverativ (Sanofi), and CSL Behring.
- Rebinyn's key competitors are:
- Idelvion (CSL Behring)
- Spectrum's Afstyla
Pricing Environment
Current Pricing Benchmarks
- In the U.S., Rebinyn's wholesale acquisition cost (WAC) is approximately USD 0.80 per IU.
- Typical treatment regimens involve weekly doses of 40-60 IU/kg.
- Cost per treatment cycle (assuming 50 IU/kg/week for a 70 kg patient) approximates USD 2,600.
Reimbursement and Insurance Impact
- Reimbursement rates vary by payer and region.
- Commercial insurance covers a significant portion, with copays around 10-20%.
Price Trends
- Prices for recombinant factor IX products have remained relatively stable over the last five years, with slight increases (~3-5% annually).
- Extended half-life products command a premium of 10-15% over standard products, due to convenience and reduced infusion needs.
Market Projections and Future Pricing Outlook
| Year |
Estimated Global Revenue (USD billion) |
Projected Price per IU (USD) |
Notes |
| 2023 |
0.36 |
USD 0.80 |
Current market size, steady pricing. |
| 2025 |
0.42 |
USD 0.85 |
Slight price increase, increased uptake. |
| 2028 |
0.50 |
USD 0.90 |
Market maturation; increase driven by new formulations. |
Influencing Factors
- Regulatory environment: Approvals of biosimilar products could exert downward pressure on prices.
- Competitive innovations: Longer-acting, gene therapies, and alternative delivery methods may impact market share and pricing.
- Market penetration: Emerging markets could see lower prices due to pricing pressures and reimbursement constraints.
- Manufacturing costs: Stable, with minor influences from raw material prices and technological improvements.
Risks to Price Stability
- Entry of cost-effective biosimilars.
- Changes in patent exclusivity, patent cliffs, and patent litigation.
- Evolving treatment guidelines favoring gene therapies over recombinant products.
Key Takeaways
- NDC 43598-0581 (Rebinyn) operates in a stable, mature market with modest growth expectations.
- U.S. pricing remains around USD 0.80 per IU, with potential for slight increases based on demand.
- The global market is projected to grow to USD 4.3 billion by 2028, driven by unmet needs and improved diagnostics.
- Competition and biosimilar entries will pressure prices downward, although premium pricing for extended half-life products persists.
- Cost drivers include patient demand, treatment guidelines, regional reimbursement policies, and innovation trajectories.
FAQs
What factors influence the pricing of Rebinyn?
Pricing depends on manufacturing costs, demand, reimbursement policies, competitive products, and regulatory changes.
How might biosimilars affect Rebinyn's market share?
Biosimilars could lead to price reductions of 20-30%, decreasing revenue margins for innovator products like Rebinyn.
Are there upcoming regulatory changes that could impact pricing?
Potential biosimilar approvals and shifts in treatment guidelines may influence the competitive landscape and prices.
What is the forecasted demand for Hemophilia B treatments?
Demand is expected to grow at a CAGR of 3.2%, driven by increased diagnosis and longer treatment durations.
How does Rebinyn compare price-wise to other long-acting factor IX products?
Rebinyn's price per IU is comparable to other long-acting products like Idelvion, typically at USD 0.80–0.90 per IU, with differences attributable to manufacturer pricing strategies.
Sources
- Fortune Business Insights. (2022). Hemophilia Market Size, Share & Industry Analysis.
- FDA. (2018). Rebinyn (coagulation factor IX, recombinant) approval documentation.
- IQVIA. (2022). Hemophilia treatment market reports.
- EvaluatePharma. (2022). Hemophilia therapies pipeline and pricing trends.
- BioCentury. (2022). Biosimilar competition and impact.
