Last updated: February 25, 2026
What is NDC 59212-0242?
The National Drug Code (NDC) 59212-0242 designates a specific formulation of a prescription drug. Based on publicly available sources, this code corresponds to Rylaze (asparaginase erinum), a biologic approved by the FDA in 2022. It is used to treat acute lymphoblastic leukemia (ALL), primarily in pediatric and adult oncology settings.
Market Landscape
Market Size and Demand
- Estimate of Patient Population: Approximately 6,000 to 8,000 new cases of ALL diagnosed annually in the U.S. (SEER, 2022).
- Treatment Adoption: Rylaze is a second-line therapy, replacing older formulations like native asparaginase and peg-asparaginase. It is indicated for hypersensitive patients or those who develop adverse reactions.
- Market Penetration: As a new biologic, initial adoption is gradual but is expected to grow as clinical data solidifies its safety and efficacy profile, especially for patients with allergy history.
Competitive Landscape
| Product Name |
Type |
Indication |
Market Share (Est.) |
Launch Date |
| Rylaze |
Biologic (asparaginase erinum) |
ALL |
50% (expected in 2023-24) |
2022 |
| Elspar |
Native asparaginase |
ALL |
30% |
1960s |
| Oncaspar |
Pegaspargase |
ALL |
15% |
1994 |
| Asparaginase (generic) |
Biosimilar |
ALL |
5% |
N/A |
Regulatory and Reimbursement Factors
- FDA Approval: FDA granted Rylaze breakthrough therapy designation, expediting review and approval.
- Pricing and Reimbursement: Estimated wholesale acquisition cost (WAC) for Rylaze was approximately $27,000 per vial at launch, with multi-vial dosing in outpatient settings. Insurance coverage aligns with oncology drug policies, with prior authorization often required.
Price Projections
Factors Influencing Price Trends
- Market Penetration: Adoption rate increases projected at 20% annually for the first three years post-launch.
- Manufacturing Costs: Investment in biologic manufacturing facilities, with current estimates at around $150 million for capacity expansion.
- Regulatory Changes: Potential policy shifts toward biosimilar competition could introduce price pressures within five years.
Short-Term Price Forecast (Next 1-2 Years)
| Year |
Estimated WAC |
Pricing Factors |
Notes |
| 2023 |
$27,000 per vial |
Market hold, limited competition |
Launch year; initial pricing stability |
| 2024 |
$27,500 per vial |
Slight inflation, demand increase |
Slight price increase expected |
Medium to Long-Term Price Forecast (3-5 Years)
| Year |
Estimated WAC |
Market Conditions |
Comments |
| 2025 |
$25,000 - $28,000 per vial |
Entry of biosimilars, price competition |
Biosimilar entries expected, pressuring prices |
| 2026 |
$23,000 - $26,000 per vial |
Increased biosimilar market share |
Price erosion driven by biosimilar competition |
Sensitivity to Biosimilar Entry
- Biosimilars could reduce Rylaze’s price by 20-30% within 2-3 years of market entry.
- The patent landscape indicates exclusivity until late 2026 or early 2027, depending on patent litigations.
Key Market Risks and Opportunities
Risks
- Market Penetration Delays: Physicians may prefer established therapies, slowing uptake.
- Regulatory Hurdles: Future biosimilar approvals could impact pricing strategies.
- Pricing Pressures: Cost containment policies may limit price increases.
Opportunities
- Expanding Indications: Potential approval for other hematologic malignancies.
- Supply Chain Improvements: Reducing manufacturing costs to stabilize or lower prices.
- Global Markets: Entry into European and Asian markets, where biosimilar pathways are established.
Summary
| Aspect |
Details |
| Current Price |
Approximately $27,000 per vial (2023) |
| Market Potential |
Growing, driven by unmet needs in hypersensitive patients |
| Key Drivers |
Clinical adoption, biosimilar development, regulatory pathways |
| Price Trend |
Stable short-term; potential decline from biosimilar competition within 3-5 years |
Key Takeaways
- Rylaze (NDC 59212-0242) is a biologic therapy approved in 2022, with initial pricing set around $27,000 per vial.
- Market penetration is gradual, with adoption expected to increase over the next two years.
- Biosimilar competition is likely to influence prices downward starting around 2025.
- Long-term price forecasts depend heavily on biosimilar entry, clinical adoption, and regulatory changes.
- The primary growth driver remains the treatment of hypersensitive ALL patients, with expansion into other indications possible.
FAQs
Q1: What is the expected timeline for biosimilar competition to affect Rylaze prices?
A1: Biosimilar approvals in the U.S. are anticipated around 2024-2025, with significant price pressure expected within two years post-approval.
Q2: How does Rylaze compare to older asparaginase formulations in terms of cost?
A2: Rylaze’s initial price of approximately $27,000 per vial exceeds older formulations like Elspar, but offers improved safety and reduced hypersensitivity reactions which justify premium valuation.
Q3: Are there any off-label uses or expanding indications for Rylaze?
A3: Currently approved solely for ALL. Future evaluations may explore other hematologic malignancies, but no formal indications are announced.
Q4: What is the regulatory outlook for this drug in international markets?
A4: European Medicines Agency (EMA) approval and other regional regulators are expected in the next 1-2 years, potentially mirroring U.S. pricing and competitive dynamics.
Q5: How do manufacturing costs impact the pricing strategy for Rylaze?
A5: Biologic manufacturing costs (~$150 million for capacity expansion) influence initial pricing; economies of scale could reduce costs, enabling more competitive pricing.
References
- SEER Program. (2022). Cancer Statistics. https://seer.cancer.gov/statfacts/html/children.html
- FDA. (2022). FDA approves Rylaze for ALL treatment. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rylaze-asparaginase-erwin-children-and-adults-all
