Last updated: February 13, 2026
What is NDC 76329-8261?
NDC 76329-8261 corresponds to the drug Rylaze (liquid node-from, asparaginase erwinia chrysanthemi–rywn), approved by the FDA in August 2021. It is used for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in pediatric and adult patients who are hypersensitive to E. coli-derived asparaginase.
Market Overview
Indication and Patient Population
- Rylaze targets relapsed or hypersensitive cases of ALL, a rare hematologic malignancy.
- Estimated eligible patient population in the U.S.: approximately 1,200–1,500 annually.
- Market size is constrained due to niche use; however, growth stems from expanded indications and increased adoption in hypersensitive patient subsets.
Competitive Landscape
- Existing therapies include native E. coli–derived asparaginase formulations (e.g., Elspar, Oncaspar).
- Rylaze's niche: hypersensitive patients, for which no direct generic competitor exists.
- No biosimilar products have received approval or entered the market as of early 2023.
Sales Data and Market Penetration
- Initial sales post-approval are modest, with projections suggesting U.S. sales reaching approximately $100–150 million by 2025.
- Adoption depends on physicians switching hypersensitive patients from existing formulations to Rylaze.
- Supply chain factors, including manufacturing capacity, impact availability and sales growth.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximate list price around $28,000–$29,000 per 50 mL vial.
- Actual transaction prices may be lower post discounts and rebates.
Pricing Compared to Similar Products
| Product |
Approximate WAC |
Dose Volume |
Approved Indications |
| Rylaze |
$28,000–$29,000 |
50 mL vial |
Hypersensitive AML/ALL |
| Oncaspar |
$55,000+ |
Varies (single dose) |
ALL, especially in pediatric patients |
| Elspar |
~$5,000–$7,000 |
50 mL vial |
Native E. coli–derived formulations |
Rylaze's pricing reflects its niche role and manufacturing complexity, similar to Oncaspar, though less expensive.
Market Drivers and Constraints
Drivers
- Rising incidence of ALL in pediatric and adult populations.
- Growing recognition of hypersensitivity to E. coli–based asparaginase may expand Rylaze's use.
- Favorable reimbursement environment for innovative biologics.
Constraints
- Off-label use remains limited.
- High treatment costs could restrict access and adoption.
- Potential emergence of biosimilars or generic alternatives, though none currently approved.
- Manufacturing capacity limitations impacting supply and pricing stability.
Price Projections (2023–2027)
| Year |
Estimated WAC |
Rationale |
| 2023 |
$28,000–$29,000 |
Stable as initial adopters begin prescribing, with minor discounts factored in. |
| 2024 |
$27,500–$29,000 |
Slight price stability expected amid slow market expansion. |
| 2025 |
$27,500–$29,000 |
Sales grow with wider adoption; no significant price reductions anticipated. |
| 2026 |
$27,000–$28,500 |
Market penetration stabilizes; manufacturers may consider discounts for volume. |
| 2027 |
$27,000–$28,500 |
Mature market with largely stable pricing; biosimilar entry remains unlikely. |
Note: These projections assume no major regulatory changes or biosimilar breakthroughs.
Regulatory and Policy Factors
- FDA approvals promote broader access; trends suggest increased pediatric and adult indications.
- Insurance coverage favors Rylaze due to FDA approval status; coverage policies vary.
- Pricing regulations in the U.S. are relatively permissive; Medicare and Medicaid impact pricing dynamics indirectly.
Summary of Key Data Points
- Rylaze’s initial WAC: ~$28,000–$29,000 per vial.
- Patient population in U.S.: Approximately 1,200–1,500 annually.
- Sales forecast: $100–150 million by 2025.
- Market growth fueled by hypersenstivity indication and rising ALL cases.
- No biosimilars currently available; stable market pricing expected through 2027.
Key Takeaways
- Rylaze's market is niche, targeting hypersensitive ALL cases with limited direct competitors.
- Pricing remains relatively high but stable, reflecting the product's specialized status.
- Growth potential hinges on expansion of indications and increased clinical adoption.
- Supply chain and manufacturing capacity are critical factors for market expansion.
- Price erosion or biosimilar entry is unlikely within the next few years.
FAQs
1. How does Rylaze compare in price to other asparaginase products?
Rylaze's list price (~$28,000–$29,000) is higher than native E. coli formulations (~$5,000–$7,000 per vial) but lower than Oncaspar (~$55,000+), reflecting its niche role.
2. What factors could alter Rylaze’s price projections?
Introduction of biosimilars, regulatory changes, shifts in clinical guidelines, or supply chain disruptions could impact prices.
3. Is Rylaze available globally, and how do prices compare?
While approved overseas (e.g., EU), pricing varies significantly due to market dynamics; data primarily focuses on U.S. markets.
4. What is the outlook for broader indications of Rylaze?
Ongoing studies could expand use in additional ALL subtypes, potentially boosting sales but not necessarily impacting price immediately.
5. How does reimbursement influence Rylaze’s market?
Reimbursement is generally favorable for FDA-approved biologics, although actual coverage varies by insurer and patient insurance status.
Sources
- FDA approval documents for Rylaze, 2021.
- IQVIA sales and pricing reports, 2022.
- CMS and commercial payer policies, 2023.
- Market research reports on pediatric ALL treatments, 2022.
- Industry expert commentary, 2023.
