Last updated: February 21, 2026
What is NDC 54838-0501?
NDC 54838-0501 refers to a specific drug product listed in the National Drug Code directory. Based on available data, this NDC corresponds to Rylaze (for use in the treatment of lymphoblastic leukemia). It is manufactured by Jazz Pharmaceuticals and was approved by the FDA in 2021.
Market Overview
Therapeutic Area and Patient Population
- Indication: Rylaze treats acute lymphoblastic leukemia (ALL) in pediatric and adult patients, primarily used to reduce asparagine levels during chemotherapy.
- Patient estimates: Approximately 6,000-8,000 new cases of ALL diagnosed annually in the U.S. (SEER, 2022).
Market Access and Reimbursement
- Pricing: Rylaze is priced at approximately $28,200 per vial (varies by supplier and contract terms).
- Coverage: Market access depends on insurance formularies, with inclusion through major payers such as CMS, private insurers, and pharmacy benefit managers (PBMs).
Competitive Landscape
- Direct Competition: Limited, with emerging biosimilar candidates unlikely due to COVID-19 pandemic delays and patent protections.
- Alternative Therapies: Chemotherapy regimens and supportive care drugs with different mechanisms.
Current Market Dynamics
| Factor |
Details |
| Market Penetration |
Limited, mainly in specialized oncology centers. |
| Adoption Rate |
Low but expected to grow with increased indication acceptance. |
| Manufacturing Data |
Limited public info; Jazz Pharmaceuticals controls production. |
Regulatory and Manufacturing Constraints
- FDA approval: 2021, with a primary orphan drug designation.
- Manufacturing: Complex bioconjugate processes, impacting supply and cost.
Market Growth Drivers
- Rising incidence of ALL.
- Expansion of indications to broader patient populations.
- Increasing awareness among oncologists.
Barriers to Growth
- High per-treatment costs.
- Limited awareness outside specialized centers.
- Competitive biotechnological developments.
Price Projections
Short-term (1-2 years)
- Price inflation constrained by payer negotiations and generic biosimilars, if developed.
- Estimated stable price at around $28,000–$30,000 per vial.
Medium-term (3-5 years)
- Potential price decrease of 10-15% if biosimilar competitors enter the market.
- Price stabilization expected if patent protections extend or are renewed.
Long-term (5+ years)
- Price could decline further, approaching $20,000–$25,000 per vial, contingent on biosimilar market entry and market dynamics.
- Market penetration will influence volume, impacting overall sales despite per-unit price changes.
| Scenario |
Price Range per vial |
Key Assumption |
| Conservative |
$28,000–$30,000 |
No biosimilar entry; market growth steady. |
| Moderate |
$22,000–$26,000 |
Biosimilar competition emerges after 3-4 years. |
| Aggressive |
<$20,000 |
Multiple biosimilars; market commoditization. |
Key Factors Influencing Price and Market Size
- Regulatory developments: Approvals of biosimilars and new indications.
- Market uptake: Adoption speed in treatment protocols.
- Pricing policies: Payer negotiations, place on formularies, and cost-sharing limits.
- Patent status: Patent expiry timeline (anticipated around 2030–2035).
Competitive and Regulatory Outlook
- Biosimilar pipeline: No biosimilars approved as of 2023 for Rylaze; potential candidates are in early development stages.
- Regulatory actions: FDA initiatives to promote biosimilar competition may influence prices.
Final Summary
The current market for NDC 54838-0501, Rylaze, is characterized by limited competition and high price points driven by its orphan drug status and specialized oncology use. Price stability is expected in the short term, with moderate declines possible in the medium term depending on biosimilar entry and market adoption. The total market size remains constrained by the relatively small patient population, but growth factors include rising leukemia diagnoses and potential new indications.
Key Takeaways
- Rylaze (NDC 54838-0501) has a stable price around $28,000 per vial, with limited near-term downward pressure.
- Market growth depends on increasing treatment adoption and approval of biosimilars.
- The total addressable market for this drug is approximately 6,000–8,000 patients annually in the U.S.
- Market entry barriers include manufacturing complexity and regulatory constraints.
- Long-term price decline could reach 20-30% if biosimilar competition develops within 5 years.
5 FAQs
Q1: What is the primary therapeutic use of NDC 54838-0501?
A: It is used to treat acute lymphoblastic leukemia (ALL), particularly during chemotherapy to reduce asparagine levels.
Q2: What is the current price per vial?
A: Approximately $28,000, subject to negotiations and contractual discounts.
Q3: Are biosimilars available for this drug?
A: No approved biosimilars as of 2023; development is ongoing.
Q4: What factors could affect future pricing?
A: Entry of biosimilars, regulatory approvals for new indications, and insurance reimbursement policies.
Q5: What is the expected market size?
A: Approximately 6,000–8,000 new cases annually in the U.S.
References
[1] SEER Cancer Statistics Review, 2022. National Cancer Institute.
[2] FDA Approval Letter for Rylaze, 2021.
[3] IQVIA, 2023. National Prescription Data.
[4] Jazz Pharmaceuticals, 2023. Rylaze Prescribing Information.
