Last updated: February 27, 2026
What is the drug associated with NDC 00641-6059?
The National Drug Code (NDC) 00641-6059 corresponds to Rylaze (asparaginase erwinia chrysanthemi), approved by the FDA for the treatment of acute lymphoblastic leukemia (ALL) in patients who have developed hypersensitivity to E. coli-derived asparaginase.
Market Overview
Indication and Patient Population
- Indication: Rylaze is indicated for managing hypersensitivity to E. coli-derived asparaginase.
- Patient Population: Primarily pediatric and adult patients with ALL. Estimated annual global incidence of ALL: approximately 6.3 per 100,000 people, with pediatric cases constituting about 80% of new diagnoses.
Competitive Landscape
- Rylaze is used when first-line asparaginase therapy fails due to hypersensitivity.
- Main competitors include Oncaspar (pegaspargase), which is derived from E. coli, but used for different indications and with different dosing.
- Limited alternative therapies approved specifically for hypersensitive patients; thus, Rylaze occupies a niche.
Market Drivers
- Growing incidence of ALL, particularly in pediatric populations.
- Increased awareness and diagnosis.
- Expanded labeling for adolescents and adults.
- Potential for use in combination therapies, improving therapeutic outcomes.
Market Challenges
- High treatment costs.
- Limited awareness in emerging markets.
- Competitive pricing pressures from generic formulations of E. coli-asparaginase.
Current Pricing and Cost Trends
Price Data (as of early 2023)
| Region |
List Price per Vial |
Cost per Course |
Notes |
| U.S. |
~$41,000 |
$164,000 (assuming 4-vial course) |
Price varies with dosage and insurance coverage |
| EU |
€35,000 (~$38,000) |
Varies, similar dosing |
Pricing influenced by national reimbursement schemes |
| Canada |
CAD 53,000 (~$41,200) |
Similar to U.S. |
Price controls impact pricing dynamics |
Note: The typical dose for Rylaze is 25,000 Units per vial, with courses dosing up to 4 vials.
Historical Price Trajectory
- 2020–2022: Prices remained relatively stable amid limited manufacturing pressures.
- 2023: Slight increases driven by inflation, manufacturing costs, and new smaller vial sizes.
- Pricing pressures: From biosIMILAR attempts and generic competition for off-label utilization.
Price Projection Outlook
Short-term (2023–2025)
- Expect mid-single-digit growth (~3-5%) annually due to inflation, increased demand, and expanded indications.
- No significant price reductions expected barring regulatory or patent developments.
Medium to Long-term (2025–2030)
- Possible price stabilization post-patent expiration, if biosimilars or generics enter the market.
- Price declines of 15-20% possible over 5–7 years if biosimilar competition gains market share.
- Inventory customization and smaller vial options may influence pricing structures.
Factors Impacting Price Trajectory
- Regulatory decisions: Patent extensions or generic approvals could alter pricing.
- Market penetration: Broad adoption in developing countries could pressure prices downward.
- Manufacturing costs: Advances in biotechnological production could reduce costs.
Market Size and Revenue Projections
- 2022 global sales estimate: Approximately $250 million, assuming 6,000 annual patient courses at $41,000 each.
- Forecast for 2023–2025: Growth to around $275–$290 million driven by increased diagnosis and expanded use.
- Long-term forecast: Potential plateau or decline if biosimilars are introduced, with a projected market value of approximately $150–$180 million by 2030.
Key Takeaways
- NDC 00641-6059 (Rylaze) occupies a niche in the ALL treatment market for hypersensitive patients.
- Market growth is driven by rising ALL incidence, especially in pediatric populations.
- Pricing remains high but is subject to moderate annual increases; significant reductions are likely if biosimilar competition emerges.
- Market size reflects steady growth; long-term prospects hinge on regulatory and competitive developments.
FAQs
1. What factors are most influential in Rylaze’s future pricing?
Patent status, biosimilar entry, manufacturing costs, and regulatory approval for broader indications.
2. How does Rylaze compare price-wise with competitors?
It commands a premium over off-label or generic asparaginase products due to specialized indications and manufacturing complexities.
3. Will biosimilars significantly impact Rylaze’s market share?
Potentially, if biosimilars gain approval and enter markets with competitive pricing strategies, leading to notable price reductions.
4. Are there upcoming regulatory changes expected to influence prices?
Possible patent expirations and approval pathways for biosimilars could influence pricing dynamics.
5. What are the primary market risks for Rylaze revenue growth?
Entry of biosimilars, shifts in treatment protocols, and reimbursement challenges in emerging markets.
References
- Food and Drug Administration. (2022). FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
- IQVIA. (2023). Market Dynamics and Pricing Trends in Oncology Biologics.
- National Cancer Institute. (2022). Incidence and Survival Data for Leukemia.
- EvaluatePharma. (2023). Oncology Market Outlook.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement and Pricing Policies.
[1] Food and Drug Administration. (2022). FDA Approved Drug Products.
[2] IQVIA. (2023). Market Dynamics and Pricing Trends in Oncology Biologics.
[3] National Cancer Institute. (2022). Incidence and Survival Data for Leukemia.
[4] EvaluatePharma. (2023). Oncology Market Outlook.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement and Pricing Policies.
