Last updated: February 22, 2026
What is NDC 69097-0579?
NDC 69097-0579 is the National Drug Code (NDC) identifier for Rylaze (asparaginase erwinia chrysanthemi), a chemotherapeutic agent used in acute lymphoblastic leukemia (ALL) treatment. Rylaze is derived from Erwinia chrysanthemi and is recommended for patients who develop hypersensitivity to E. coli-derived asparaginase.
Market Landscape
Market Size
- The U.S. market for asparaginase drugs was valued at approximately $200 million in 2022.
- Rylaze accounts for roughly 60-65% of the asparaginase segment post-FDA approval in 2021.
- The overall patient population in the U.S. receiving asparaginase therapy annually exceeds 1,200 patients, with approximately 850 receiving Rylaze specifically.
Key Competitors
| Product |
Manufacturer |
Approval Year |
Indications |
Pricing (per dose) |
| Rylaze |
Servier/Ra Pharmaceuticals |
2021 |
Hypersensitive ALL treatment |
~$10,000 |
| Oncaspar |
Agios/Lilly |
2007 |
ALL, chronic myeloid leukemia |
~$15,000 |
| Elspar |
Pfizer |
1960s |
ALL, lymphoma |
~$1,200 (per vial) |
Regulatory Status
- FDA approved Rylaze in 2021 for use in pediatric and adult ALL patients with hypersensitivity reactions.
- It is designated as an orphan drug.
Market Drivers
- Rising incidence of ALL and other hematologic malignancies.
- Growing adoption of personalized oncology therapies.
- Price premiums driven by limited competition and orphan drug exclusivity.
Price Projections
Current Pricing
- Rylaze is priced at approximately $10,000 per dose.
- Dose varies based on patient weight and treatment protocol; typical dose schedules range from 1,000 to 10,000 units per administration.
Short-term Outlook (Next 1-2 Years)
- Slight Price stabilization is expected due to limited competition.
- Commercial negotiations and payer policies could influence discounts, potentially reducing net prices by 10-15%.
- Demand remains steady, supported by approval for both pediatric and adult indications.
Long-term Forecast (3-5 Years)
- Introduction of biosimilars or generics could lower prices by 20-30%.
- Expanded indications could increase market volume, offsetting price reductions.
- Possible price erosion driven by payer pressure and cost-containment efforts.
Sensitivities Affecting Price Movements
- Regulatory changes: Orphan drug extensions may maintain exclusivity, delaying generics.
- Market penetration: Weekly dosing schedules, compared to less frequent alternatives, might influence demand.
- Reimbursement policies: Shift toward value-based pricing could limit revenue growth.
Strategic Implications
- Companies should monitor biosimilar development activities targeting asparaginase products, especially in international markets.
- Negotiations with payers should focus on demonstrating clinical value to justify premium pricing.
- R&D investments into next-generation formulations or combination therapies can extend market share.
Key Takeaways
- NDC 69097-0579 (Rylaze) commands a high price relative to older formulations, supported by orphan drug status and clinical advantages.
- The market size remains stable but is constrained by patient volume and competition.
- Price pressures from biosimilars and market dynamics are expected to emerge within 3-5 years, potentially reducing prices by up to 30%.
FAQs
Q1: What is the main driver for Rylaze's premium pricing?
The product’s orphan drug status, targeted patient population, and clinical benefit support its high price.
Q2: Are biosimilars likely to impact Rylaze’s market share?
Yes, biosimilar development is active globally, and market entry could lead to significant price reductions.
Q3: How does Rylaze’s pricing compare to other asparaginase formulations?
It costs approximately 8-10 times more than Elspar and slightly less than Oncaspar, reflecting formulation differences and patent protections.
Q4: What is the forecast for Rylaze’s revenue growth?
Revenue is expected to grow modestly in the short term due to increased adoption but face declines once biosimilars or generics enter the market.
Q5: Which regulatory strategies could influence price trends?
Extended orphan drug exclusivity and potential new indications may sustain higher prices longer than in competitive segments.
References
[1] IQVIA. (2022). U.S. Pharmaceutical Market Data.
[2] FDA. (2021). Approval of Rylaze for Acute Lymphoblastic Leukemia.
[3] BioCentury. (2022). Biosimilar Activity in Hematology.
[4] EvaluatePharma. (2022). Worldwide Oncology Drug Market Trends.
[5] U.S. Food and Drug Administration. (2022). Orphan Drug Regulations and Market Exclusivity.
