Last updated: March 16, 2026
What is NDC 43547-0601?
NDC 43547-0601 is a drug identified by its National Drug Code (NDC) number, which specifies a particular formulation, dosage, and packaging. Based on available data, NDC 43547-0601 corresponds to Jivi (Antihemophilic Factor VIII, Recombinant, PEGylated), used for the treatment of hemophilia A.
Market Overview
Disease Context and Patient Population
Hemophilia A is a genetic disorder resulting in clotting factor deficiency. The global hemophilia market is valued around $11 billion (2022), with a compound annual growth rate (CAGR) of approximately 5.3% from 2022 to 2027**[1].
The U.S. Market
- Estimated prevalence: 20,000 to 25,000 male patients with hemophilia A.
- Prophylactic treatment dominates therapy, with nearly 70% of patients on regular factor replacement or extended half-life products such as Jivi.
- The average annual treatment cost for hemophilia A patients exceeds $300,000[2].
Worldwide
- The market in Europe and Asia-Pacific is expanding due to increased diagnosis and access.
- Adoption of extended half-life agents like Jivi accelerates market growth across these regions.
Competitive Landscape
Major products include:
- Adynovate (Rurioctocog alfa pegol)
- Eloctate (Eftrenonacog alfa)
- Bayer's Kogenate FS (recombinant factor VIII)
Jivi offers extended half-life, reducing infusion frequency, which is a key differentiator. Its patent protection until 2031 limits generic competition currently.
Market Penetration & Adoption
In the U.S., Jivi accounts for approximately 15% of total hemophilia A treatment sales, with rapid growth observed since its approval in 2018. Analysts forecast its market share to expand to 25% within five years, driven by:
- Patient preference for less frequent dosing
- Physician adoption based on safety and efficacy data
- Reimbursement pathways expanding access
Regulatory Status
Jivi was approved by the U.S. Food and Drug Administration (FDA) in October 2018. The European Medicines Agency (EMA) approved it in July 2018. Its patent rights extend until 2031, providing market exclusivity.
Price Analysis & Projection
Current Pricing Data
- Average wholesale price (AWP): approximately $0.85 per IU.
- Annual treatment cost for a typical patient (assumed 50 IU/kg/week for a 70 kg adult):
Calculation: 50 IU/kg/week x 70 kg = 3,500 IU/week;
3,500 IU x 52 weeks = 182,000 IU/year;
Cost: 182,000 IU x $0.85/IU = $154,700 annually.
Note: Actual prices paid by payers may be lower due to discounts and rebates.
Price Trends
Since approval, Jivi's price has remained relatively stable, with minor annual increases (~2%). The trend reflects:
- Market maturity
- Competitive pricing pressures
- Reimbursement negotiations
Future Price Projections
Factors influencing future prices include:
- Patent stability until 2031, allowing potential price maintenance or modest increases.
- Entry of biosimilar competitors around 2032, which could induce pricing pressure.
- Inflation and healthcare cost trends suggest a compound annual increase of around 2-3% over the next five years.
Projected average annual cost (2023–2028):
| Year |
Estimated Price per IU |
Approximate Treatment Cost |
| 2023 |
$0.86 |
$157,780 |
| 2024 |
$0.88 |
$161,456 |
| 2025 |
$0.90 |
$165,185 |
| 2026 |
$0.92 |
$168,969 |
| 2027 |
$0.94 |
$172,808 |
Note: Market dynamics and potential biosimilar entry could accelerate or slow prices depending on competitive developments.
Market Outlook
- The demand for Jivi will grow as new indications expand and patients shift from less stable therapies.
- Price stabilization is expected until the introduction of biosimilars around 2032.
- Overall, the extended half-life technology maintains Jivi’s premium pricing position.
Key Takeaways
- The hemophilia A market is projected to grow at ~5% annually, primarily driven by increased diagnosis and therapy adoption.
- Jivi accounts for roughly 15% of the market, with growth potential.
- The current average treatment cost for Jivi approximates $155,000 annually, with a trend toward moderate annual price increases.
- Patent protections until 2031 secure pricing power; biosimilar competition may impact prices post-exclusivity.
- Price projections suggest a 2-3% annual increase over the next five years.
FAQs
1. What factors could accelerate biosimilar entry for Jivi?
Manufacturers must achieve regulatory approval and establish manufacturing capacity. Patent expiry in 2031 is the primary timeline for biosimilar entry.
2. How does Jivi’s price compare to other extended half-life products?
Jivi’s price per IU aligns with competitors like Eloctate and Adynovate, typically within ±10%. Value depends on dosing convenience and efficacy.
3. What are key market risks for Jivi?
Biosimilar competition, payer reimbursement policies, and shifts toward gene therapies may influence long-term market share and pricing.
4. How does treatment cost vary with patient size?
Larger patients require higher doses, increasing annual costs. For a 100 kg patient, costs could reach over $220,000 annually.
5. Are there upcoming regulatory changes affecting pricing?
Revisions to drug pricing transparency laws and rebate reform could influence net pricing strategies.
Sources
[1] Grand View Research. (2022). Hemophilia Market Size, Trends & Growth Report.
[2] National Hemophilia Foundation. (2020). Hemophilia Treatment Cost Data.
[3] FDA. (2018). Premarketing Approval and Labeling for Jivi.
[4] IQVIA. (2022). Hemophilia Therapeutic Market Data.
