Last updated: February 24, 2026
What Is NDC 00378-3515?
NDC 00378-3515 refers to a specific drug formulation listed in the National Drug Code (NDC) database. Based on its coding structure, it is identified as an injectable medication, likely used in hospital or specialty settings. According to the FDA’s NDC Directory, this code corresponds to Aldesleukin (interleukin-2), used mainly for metastatic renal cell carcinoma and metastatic melanoma.
Market Size and Dynamics
Current Market Overview
Aldesleukin, marketed under Proleukin, holds a niche position within immunotherapy. Its recent sales are primarily driven by niche indications, with limited off-label use. The global markets for immuno-oncology drugs are growing at a compound annual growth rate (CAGR) of approximately 8-10% (2022–2027).
Indications and Usage
- Meta. renal cell carcinoma
- Melanoma (metastatic)
- Use is restricted to specialized settings due to toxicity profile
Competitive Landscape
Major competitors include checkpoint inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo), which have broader indications. These drugs record global sales exceeding $40 billion annually, overshadowing the relatively small niche of Aldesleukin.
Reimbursement and Adoption Trends
Reimbursement remains favorable in oncology-focused centers. Usage is limited by toxicity concerns and intravenous administration requirements. Adoption is stable but constrained, with no recent FDA label expansion.
Price Trends and Projections
Historical Pricing Data
- Current Wholesale Acquisition Cost (WAC): Approximately $10,000 per 50-mcg vial (per AWP, as of 2022).
- Average Selling Price (ASP): Estimated around $8,500 per vial.
- Pricing trend (2018–2022): Slight increase (~3% annually), driven by manufacturing costs, demand, and market dynamics.
Future Price Projections
| Year |
Estimated WAC |
Comments |
| 2023 |
$10,300 |
Slight increase driven by inflation and regulatory costs. |
| 2024 |
$10,600 |
Expected stabilizations as manufacturing efficiencies improve. |
| 2025 |
$11,000 |
Potential inflation adjustments; limited price competition. |
| 2026 |
$11,400 |
Market saturation unlikely to depress prices significantly. |
Factors Influencing Price Changes
- Manufacturing Cost: High due to complex biotech production; unchanged supply chain.
- Market Demand: Stable within niche markets; unlikely to see rapid price drops.
- Regulatory Changes: No significant updates announced; potential for price control measures unlikely.
- Competitive Environment: No direct biosimilar competition currently; a biosimilar pathway remains complex due to the molecular nature.
Regulatory and Policy Impact
No recent FDA approvals or label modifications are expected to influence the price significantly. Policy developments, such as Medicare drug price negotiations, could apply pressure after 2025 but are unlikely to impact this niche product immediately.
Strategic Considerations for Stakeholders
- Manufacturers can expect stable pricing with modest annual increases.
- Investors should see limited appreciation potential unless new indications or expanded approvals occur.
- Healthcare providers will remain limited to niche use due to toxicity and administration constraints.
Summary
NDC 00378-3515 (Aldesleukin) operates in a small, stable market with annual price increases around 3%. The current price per vial is approximately $8,500–$10,000; projections suggest modest growth through 2026. No major shifts are expected unless new indications or biosimilar entrants alter the competitive landscape.
Key Takeaways
- The drug's niche positioning limits growth but supports stable pricing.
- Price increases are primarily driven by inflation and manufacturing costs.
- Competition from newer immunotherapies constrains potential for significant price hikes.
- Regulatory and policy factors are unlikely to impact prices in the near term.
FAQs
1. What drives the pricing of Aldesleukin?
Manufacturing complexity, demand within niche oncology indications, and inflation influence its price.
2. Are biosimilars likely to enter the market?
Biosimilar pathway exists but faces significant scientific and regulatory hurdles, delaying competition.
3. How does the drug compare to newer therapies?
It targets similar indications but has a toxicity profile and administration route that limit broader adoption compared to checkpoint inhibitors.
4. What is the outlook for pricing beyond 2026?
Limited unless new indications emerge or biosimilar competition reduces prices.
5. How is reimbursement affecting the market?
Reimbursement is generally stable for approved niche uses, with high-cost reimbursement regimens typical for specialty drugs.
References:
[1] FDA NDC Directory. (2022). U.S. Food and Drug Administration.
[2] IQVIA. (2022). National Prescription Audit.
[3] GlobalData. (2023). Oncology Market Analysis.
[4] Centers for Medicare & Medicaid Services. (2022). Price and policy updates.
