Last updated: February 27, 2026
What Is the Drug Associated with NDC 70677-1271?
NDC 70677-1271 is the National Drug Code for Jivi (Hemophilia a, recombinant, albumin-free), manufactured by Genentech. It is a recombinant analog designed for the treatment and prophylaxis of hemophilia A.
Market Overview
Disease and Population
- Hemophilia A affects approximately 1 in 5,000 male births worldwide, translating to roughly 250,000-300,000 patients globally.
- The U.S. has around 20,000 diagnosed patients, primarily on factor replacement therapy.
- Patients often require regular infusions; therapy duration varies from childhood into adulthood.
Competitors
- Bioverativ's Alprolix (eftrenonacog alfa).
- CSL Behring's Euplirna (Baxjecta).
- Shire’s Adynovate.
- Higher-cost recombinant products dominate the prophylaxis market.
Market Size and Revenue Potential
- The global hemophilia market was valued at approximately $10 billion in 2022.
- Compound annual growth rate (CAGR) stands at roughly 6-8%.
- Recombinant factors like Jivi command premiums due to ease of use; list prices range between $250,000 - $400,000 per year per patient.
Price Analysis
Current List Price and Negotiated Prices
- The average wholesale price (AWP) for Jivi is established around $300,000 per year for prophylactic use.
- Negotiated prices with payers often reduce this by 15-25%.
- In select markets, co-pay assistance programs reduce patient out-of-pocket costs.
Pricing Dynamics
- Price competition among recombinant products tends to keep prices within the $250,000-$350,000 spectrum.
- Market entry of biosimilar recombinant factor VIII products could pressure prices over the next 3-5 years.
- Price discounts are common in various payment models, including outcomes-based and pooled risk arrangements.
Market Penetration and Trends
- Jivi's approval in 2018 entered a mature market with established therapies.
- The device's convenience features could expand penetration among younger and outpatient populations.
- Increasing global access, especially in emerging markets, might elevate total sales volume.
Price Projections (2023-2028)
| Year |
Estimated Average Price |
Expected Market Share |
Projected Revenue (USD Millions) |
| 2023 |
$290,000 |
15% |
$438 |
| 2024 |
$280,000 |
20% |
$560 |
| 2025 |
$270,000 |
25% |
$675 |
| 2026 |
$260,000 |
30% |
$780 |
| 2027 |
$255,000 |
35% |
$891 |
| 2028 |
$250,000 |
40% |
$1,000 |
Assumes gradual price stabilization with slight declines due to biosimilar competition, offset by increased market penetration.
Regulatory and Reimbursement Factors
- US Centers for Medicare & Medicaid Services (CMS) has implemented drug discounts such as the Best Price rule and ASP (Average Sales Price) reimbursement.
- Market access may influence net prices, especially in countries with centralized procurement or price controls.
- Payer strategies, especially with the rise of gene therapy options, could impact long-term pricing.
Implications for Stakeholders
- Pharmaceutical companies: Price compression expected as biosimilars and gene therapies expand.
- Payers: Increased leverage to negotiate discounts.
- Patients: Potential for reduced out-of-pocket expenses through co-pay assistance and insurance negotiations.
- Investors: Stable revenue prospects within the current premium pricing model, though long-term growth may depend on biosimilar competition and treatment paradigm shifts.
Key Takeaways
- NDC 70677-1271 (Jivi) operates in a multi-billion-dollar market with stable high-price points.
- Revenue is sensitive to biosimilar entry, competitive dynamics, and evolving treatment standards.
- Near-term price stabilization around USD 250,000 - 300,000 expected, with growth driven by increasing global access.
- Long-term outlook involves potential price erosion but maintained profitability through brand loyalty and market expansion.
FAQs
Q1: When is biosimilar competition expected for Jivi?
Biosimilars for recombinant factor VIII are in development, with potential launches from 2024-2026. Their entry could reduce prices by 20-40%.
Q2: How does gene therapy affect Jivi's market?
Gene therapy offers a potential one-time cure, which could reduce demand for lifelong recombinant product therapy. Its adoption depends on efficacy, safety, and cost considerations.
Q3: What are key regions influencing Jivi’s sales?
The U.S., Europe, and Japan account for the majority of sales due to higher diagnosis rates and reimbursement infrastructure. Emerging markets are growing segments.
Q4: How do payer policies influence product pricing?
Payers negotiate discounts and implement utilization controls, influencing net prices and market share. Value-based contracts are increasingly common.
Q5: What factors could alter the projected revenue?
Emergence of new therapies, patent expirations, competitive biosimilars, and shifts in clinical guidelines could influence sales and pricing models.
References
[1] IQVIA. (2022). Hemophilia market analysis.
[2] Centers for Medicare & Medicaid Services. (2022). Average Sales Price (ASP) Pricing.
[3] EvaluatePharma. (2022). Global Hemophilia Market Report.
[4] American Society of Hematology. (2023). Hemophilia Treatment Landscape.
