Last updated: February 22, 2026
What Is the Drug Associated with NDC: 00025-1710?
The National Drug Code (NDC) 00025-1710 corresponds to Oncaspar (pegaspargase), lyophilized, indicated primarily for acute lymphoblastic leukemia (ALL) as part of multi-agent chemotherapy. The drug is marketed by Cephalon, now under the Takeda umbrella following acquisition.
Market Overview
Current Market Size
The global market for pegylated asparaginases, primarily Oncaspar, was valued at approximately USD 280 million in 2022. The U.S. accounts for over 70% of this revenue, driven by follows:
- Rising incidence of ALL.
- Adoption in pediatric and adult oncology.
- Extended indications over time, including relapsed/refractory cases.
Competitive Landscape
Key competitors include:
- Calaspargase pegol (JZP-458): FDA-approved for ALL. Marketed by Jazz Pharmaceuticals.
- Eryaspase (enco-around asparaginase): Approved for ALL and lymphoma, supplied by Jazz Pharma.
- Native E. coli asparaginase (Elspar): Older formulation, largely replaced but still in use.
The therapeutic class faces challenges related to allergic reactions, hypersensitivity, and the development of antibodies, which influence utilization.
Treatment Dynamics
- Orphan Drug Status: Oncaspar holds orphan designation, extending market exclusivity until 2024 in the U.S.
- Pricing Strategy: Currently priced at roughly USD 14,000 per vial, with variations depending on dosing and insurance coverage.
- Reimbursement: Insurers, Medicare, and Medicaid cover most cases, but high costs limit accessibility in certain settings.
Patent and Regulatory Status
- Original patent expired in 2015.
- Takeda holds exclusivity rights via orphan designation and clinical data protections.
- A biosimilar pathway is active, with development underway by multiple players, potentially entering the market in 2024-2025.
Price Projections (Next 5 Years)
Influence Factors
- Patent expiration and biosimilar entry.
- Regulatory approvals of biosimilars.
- Reimbursement policies and pricing negotiations.
- Clinical guidelines updates.
Pricing Trends
| Year |
Estimated Average Price per Dose (USD) |
Notes |
| 2023 |
USD 14,000 |
Current market price. |
| 2024 |
USD 12,500 |
Price reductions anticipated due to biosimilar entry. |
| 2025 |
USD 10,000 |
Increased biosimilar penetration reduces prices. |
| 2026 |
USD 8,000 |
Further biosimilar market share gains. |
| 2027 |
USD 7,000 |
Potential price stabilization as biosimilars dominate. |
Revenue Impact
- Pre-biosimilar period (2023-2024): Stable revenues, estimated USD 250-280 million annually.
- Post biosimilar entry (2025 onward): Revenue drops by approximately 40-60% due to competition, with total global sales declining to below USD 150 million by 2027.
Market Share Projections
| Year |
Oncaspar Market Share |
biosimilar Market Share |
Comments |
| 2023 |
90% |
10% |
Leading therapy, high brand loyalty. |
| 2024 |
60% |
40% |
Biosmilars gain ground following patent expiry. |
| 2025 |
30% |
70% |
Biosimilars dominate, Oncaspar remains in niche. |
Strategic Outlook
- Pricing pressure due to biosimilars will erode profit margins.
- R&D investments could focus on next-generation formulations or combination therapies.
- Expansion into new indications remains limited but possible if data support broader use.
Key Takeaways
- The current drug, Oncaspar, maintains a dominant share in ALL treatment but faces significant biosimilar competition starting 2024.
- Price declines are projected to accelerate post patent expiration, with average prices dropping approximately 50% over five years.
- Revenue declines will depend on biosimilar uptake and reimbursement policies.
- Manufacturers should prepare for increased competition via innovative formulations or new indications.
FAQs
How soon will biosimilar versions of pegaspagrase enter the market?
Biosimilars are expected around 2024-2025, following patent expiry and regulatory approval processes.
What impact will biosimilar entry have on existing pricing?
Prices could decrease by 30-50% within the first year of biosimilar approval, depending on competitive dynamics and insurance negotiations.
Are there any recent regulatory developments affecting Oncaspar?
Yes, FDA approved a biosimilar (JZP-458) in 2021, which is expected to compete directly with Oncaspar.
How many biosimilar candidates are in development?
At least 5 biosimilars at various stages from late-stage clinical trials to regulatory submission, with some planning for 2024-2025 approval.
What alternative therapies are emerging for ALL treatment?
Targeted therapies and CAR-T cell treatments are expanding options, potentially reducing reliance on pegylated asparaginases in specific patient groups.
Sources
[1] IQVIA. (2022). Global Oncology Market Data.
[2] FDA. (2023). Biologics Approved in 2021-2023.
[3] MarketWatch. (2023). Pegaspargase Market Size & Trends.
[4] Takeda. (2022). Oncaspar Product Information.
[5] EvaluatePharma. (2023). Biosimilar Outlook for Oncology Drugs.
