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Last Updated: April 1, 2026

Drug Price Trends for NDC 42806-0266


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Best Wholesale Price for NDC 42806-0266

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 42806-0266

Last updated: March 30, 2026

What is the drug associated with NDC 42806-0266?

NDC 42806-0266 corresponds to Rylaze (recombinant human.closest to the generic name: Asparaginase erwinia chrysanthemi), a recombinant form of asparaginase used in acute lymphoblastic leukemia (ALL) treatment. Approved by the FDA in 2021, Rylaze is the only licensed form of Erwinia asparaginase for patients allergic to native Escherichia coli asparaginase.

What is the current market landscape?

Market size and growth drivers

  • The global leukemia treatment market was valued at approximately $14.5 billion in 2021.
  • The segment specific to pediatric ALL accounts for roughly 30% of this market.
  • Market growth factors include increased incidence of ALL, incremental adoption of targeted therapies, and emerging biosimilar competition.

Key competitors

Product Type Year Approved Market Share (2022 Estimate) Notes
Rylaze (NDC 42806-0266) Recombinant asparaginase 2021 100% (initial launch) First and only FDA-approved Erwinia asparaginase
Oncaspar (Pegaspargase) PEGylated L-asparaginase 1994 60% Used in ALL, with ongoing biosimilar development
Native E. coli asparaginase Non-pegylated, older 1970s 20% Declining use due to hypersensitivity risks

Revenue projections

  • Estimated 2023 sales: $200 million based on initial uptake.
  • Forecast for 2027: $600–$800 million with increased adoption, especially in pediatric cases and in centers preferring recombinant formulations due to safety profile.

Pricing analysis

Parameter Details
Price per dose Approximately $10,000–$12,000 (per vial)
Treatment course Usually 1–2 vials, depending on patient weight and treatment plan
Reimbursement Primarily via Medicare and commercial insurers; government contracts influence pricing

Price trends

  • Rylaze 2021 launch prices set at $12,000 per vial.
  • Modest reductions anticipated as biosimilar candidates emerge post-2025.
  • Price increases with manufacturing complexity and smaller patient populations.

What are the regulatory and policy influences?

Regulatory landscape

  • The FDA approved Rylaze via the accelerated approval pathway based on surrogate endpoints.
  • Ongoing post-marketing studies aim to extend indication and confirm long-term safety and efficacy.

Market access policies

  • Payors favor formulations with lower hypersensitivity risk; recombinant Rylaze has advantages over native formulations.
  • Value-based pricing models are increasingly used, considering safety and efficacy benefits.

Biosimilar development

  • Patents for Rylaze expire around 2026–2028.
  • Several biosimilar candidates are in development, which may lead to price competition post-approval.

Implication for stakeholders

  • Pharmaceutical companies: Potential to develop biosimilars leading to price erosion.
  • Healthcare providers: Need to weigh efficacy, safety, and cost when selecting formulations.
  • Investors: Rylaze represents a high-growth niche initially but faces imminent competition from biosimilars.

Conclusion

NDC 42806-0266 (Rylaze) commands a premium due to its status as the only recombinant Erwinia asparaginase approved for hypersensitive patients. The market is poised for growth driven by expanding indications and increasing adoption, with prices around $10,000–$12,000 per vial. Regulatory expiry and biosimilar entries expected around 2026–2028 could significantly impact pricing and market share.

Key Takeaways

  • Rylaze is the primary recombinant Erwinia asparaginase, with initial revenues around $200 million in 2023.
  • Prices are set at approximately $10,000–$12,000 per vial, with incremental reductions expected following biosimilar approvals.
  • The market is limited due to small patient populations but has growth potential as adoption expands.
  • Biosimilar competition post-2026 could reduce prices by 30–50%.
  • Payer policies favor recombinant formulations due to safety, influencing market dynamics.

FAQs

  1. What is the main advantage of Rylaze over native E. coli formulations?
    Rylaze reduces hypersensitivity reactions and improves safety profiles.

  2. When are biosimilars expected to enter the market?
    Likely around 2026–2028, after patent expirations.

  3. How does pricing compare to other asparaginase products?
    Rylaze costs roughly 20–50% more than native formulations due to manufacturing complexity.

  4. What geographic markets are most lucrative for Rylaze?
    North America accounts for approximately 70% of sales; Europe and Asia-Pacific are emerging markets.

  5. What is the outlook for Rylaze's market share?
    Initially near 100%, but potential decline to 50–60% post-biosimilar entry, depending on formulary support and pricing.


Sources

  1. U.S. Food and Drug Administration. (2021). FDA approves Rylaze to treat acute lymphoblastic leukemia.
  2. EvaluatePharma. (2022). Oncology market forecasts.
  3. IQVIA. (2022). Global Oncology Market Data.
  4. National Comprehensive Cancer Network. (2022). Guidelines for ALL treatment.
  5. Biosimilar development pipeline reports (2022).

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