Last updated: March 3, 2026
What is NDC 42806-0501?
NDC 42806-0501 refers to a specific pharmaceutical product identified in the U.S. National Drug Code system. According to available data, this code corresponds to Rylaze (asparaginase erwinia chrysanthemi), injection, indicated for the treatment of acute lymphoblastic leukemia (ALL).
Market Overview
Therapeutic Landscape
Rylaze is used in the treatment of ALL, typically in patients who have developed hypersensitivity to E. coli-derived asparaginase. Its market is influenced by:
- The incidence rate of ALL in the U.S., approximately 6 per 100,000 annually.
- The adoption rate of asparaginase-based therapies in leukemia treatment protocols.
- The competitive landscape, including alternatives like peg-asparaginase (e.g., Oncaspar) and biosimilars.
Key Market Players
- Erytech Pharma: Focused on product development.
- The existing manufacturer of Rylaze (Jazz Pharmaceuticals): The sole supplier reported as of 2023.
- Potential Biosimilar Developers: No biosimilars authorized yet as of 2023.
Regulatory Status and Market Access
- Approved by the FDA in October 2021 under priority review.
- Market entry early, with limited competition.
- Insurance coverage and pricing negotiations influence revenue.
Price Analysis
Current Pricing Data
- Wholesale Acquisition Cost (WAC): Estimated at approximately $50,000 to $60,000 per vial.
- Average Treatment Course Cost: Typically requires 2 to 4 vials per cycle, depending on patient weight and dosing schedule, leading to a full course cost of approximately $100,000 to $240,000.
- List price variations are driven by dosage, packaging, and negotiated discounts.
Reimbursement Landscape
- Reimbursed primarily through Medicare, Medicaid, and private insurers.
- Average patient out-of-pocket costs depend on insurance plans but can range from $0 (if fully covered) to several thousand dollars.
Pricing Trends
| Year |
Estimated WAC per vial |
Average Course Cost |
Notes |
| 2022 |
$50,000 - $55,000 |
$100,000 - $220,000 |
Initial market entry pricing |
| 2023 |
$55,000 - $60,000 |
$110,000 - $240,000 |
No significant price reduction noted |
Factors Influencing Price Projections
- Market penetration: As usage expands, economies of scale could reduce prices marginally.
- Manufacturing costs: A likely factor for sustained high prices due to complexity.
- Potential biosimilars: Absence of immediate competitors supports pricing power.
- Payer negotiations: Reimbursement rates and drug formularies impact actual prices paid.
Market Size Projections (2023–2028)
Estimated annual U.S. sales:
- 2023: $150 million, assuming 2,500 courses sold.
- 2024–2028: Compound annual growth rate (CAGR) of 8%, driven by increasing leukemia diagnoses and adoption.
| Year |
Predicted Sales |
Market Penetration |
Comments |
| 2023 |
$150 million |
10% of target population |
Early market adoption |
| 2025 |
$210 million |
15% of target population |
Increased adoption, earlier lines of therapy |
| 2028 |
$270 million |
20% of target population |
Market expansion continues |
Key Challenges & Opportunities
Challenges
- High treatment costs may limit adoption in cost-sensitive payers.
- Competition might emerge from biosimilars, impacting pricing.
- Regulatory or safety issues could restrict market growth.
Opportunities
- Expanding indications or combination therapies.
- Developing biosimilars to create price competition.
- Enhancing formulary positioning to reduce patient costs.
Summary
NDC 42806-0501 (Rylaze) commands a high price point with minimal competition, projecting stable revenue growth in the U.S. market. Pricing remains anchored by manufacturing costs, market demand, and payer negotiations, with potential downward pressure from biosimilar entrants.
Key Takeaways
- Rylaze's current WAC per vial is approximately $55,000 to $60,000.
- Full treatment courses can reach $240,000 per patient.
- Revenue projections indicate growth at an 8% CAGR through 2028.
- Market expansion depends on broader acceptance and potential biosimilar entry.
- Pricing sustainability relies on limited competition and high clinical value.
FAQs
1. What factors could lead to a decline in Rylaze’s price?
Introduction of biosimilars, increased manufacturing efficiencies, or payer pressure can reduce prices.
2. How does Rylaze compare to other asparaginase products?
Rylaze is primarily used for hypersensitive patients, often commanding higher prices than E. coli-derived formulations.
3. What is the primary revenue driver for this drug?
The incidence of ALL and the clinical adoption rate influence revenue growth.
4. Are there regulatory barriers impacting pricing?
Yes, FDA approval and safety profiles influence market confidence, indirectly affecting pricing.
5. How will market dynamics change with biosimilar entry?
Biosimilars would likely lower prices through increased competition, possibly reducing revenue margins for the original product.
References
[1] FDA. (2021). Rylaze (asparaginase erwinia chrysanthemi) injection approval documents.
[2] IMS Health. (2022). U.S. pharmaceutical pricing and sales reports.
[3] Market Research Future. (2023). Leukemia therapeutics market analysis.
[4] Centers for Disease Control and Prevention (CDC). (2022). Incidence and prevalence of ALL.
[5] Bloomberg. (2023). Drug pricing trends and market data.
Note: Exact data reflects estimates based on current market intelligence; actual figures may vary with market developments.
