Last updated: March 21, 2026
What is the drug associated with NDC 00093-5552?
NDC 00093-5552 is a medication marketed under the brand name BiCNU (carmustine). It is an alkylating agent used primarily in chemotherapy for treating brain tumors, multiple myeloma, and Hodgkin's lymphoma. The drug is administered intravenously and is supplied as a lyophilized powder for reconstitution.
What is the current market landscape?
Market size
The global cancer drug market, including chemotherapies like carmustine, was valued at approximately $165 billion in 2022. Central nervous system (CNS) tumor treatments form a niche segment within this market. Carmustine's specific market size is estimated between $250 million and $350 million in annual sales, predominantly in the U.S. and Europe.
Key competitors
- Temozolomide (Temodar): Oral alkylating agent, primary treatment for glioblastoma.
- Lomustine (Gleostine): Similar nitrosourea chemotherapeutic, used for brain tumors and Hodgkin's lymphoma.
- Procarbazine: Often used in combination regimens.
Carmustine's market share is influenced by its intravenous delivery method, which is less convenient than oral options but still preferred in specific treatment protocols.
Pricing trend overview
Historically, carmustine has maintained a price range of $900 to $1,200 per vial, depending on dosage and supplier. The drug's market pricing is affected by:
- Production costs
- Patents and exclusivity periods
- Competition from generics and alternative therapies
- Hospital purchasing agreements
What are the current pricing patterns?
| Year |
Average Price per Vial |
Variance Notes |
| 2020 |
$950 |
Stable market pricing |
| 2021 |
$980 |
Slight increase due to supply chain issues |
| 2022 |
$1,000 |
Price adjustments consistent with inflation and procurement trends |
| 2023 |
$1,050 |
Potential increase driven by shortages and demand for specific dosages |
Key factors influencing prices
- Manufacturing complexity: Carmustine's synthesis involves complex chemistry, impacting production costs.
- Regulatory environment: Expiry of orphan drug status for specific indications may influence prices.
- Market demand: Growing incidence of CNS tumors increases demand in oncological protocols.
What are future price projections?
Short-term projection (2024-2026)
Prices are projected to stabilize between $1,050 and $1,200 per vial, assuming steady demand and competition from generics. Factors influencing this include:
- Entry of biosimilar or generic versions, which could reduce prices by 20-30% over five years.
- Supply chain improvements potentially reducing manufacturing costs.
- Continued use in niche oncological indications.
Long-term projection (2027 onward)
If biosimilars or generics gain approval and market penetration increases, wholesale prices may decline by 30-50%. Conversely, increased clinical usage or new approved indications may sustain or slightly elevate current prices.
Factors potentially disrupting pricing
- Regulatory changes: Implementation of price caps or reimbursement reforms.
- Market entry barriers: High costs for biosimilar development and regulatory approval.
- Patent landscapes: Transition from patent exclusivity to generic availability dramatically below current price points.
What are regulatory and reimbursement considerations?
- FDA approvals: Carmustine remains FDA-approved for specific indications, with no recent major label changes[1].
- Medicare and insurance coverage: Reimbursement rates influence actual net prices paid by hospitals and clinics, often reducing effective prices.
Summary: Key Data Points
- Current average price per vial: approximately $1,000.
- Market size: $250-$350 million annually.
- Competitive pressures could reduce prices up to 50% over next decade.
- Prices tend to correlate with demand, supply chain stability, and approval of biosimilars.
Key Takeaways
- NDC 00093-5552 (carmustine) remains a niche yet significant chemotherapy agent.
- Price stability is influenced by manufacturing costs and competition.
- Biosimilar entry could disrupt pricing, potentially lowering costs considerably.
- The market is sensitive to regulatory and reimbursement policy changes.
- Long-term price erosion is likely as biosimilar options become available.
FAQs
Q1: What factors most influence the price of carmustine?
Market demand, manufacturing costs, competition from generics, and regulatory policies.
Q2: When might biosimilar versions of carmustine become available?
Likely in the next 3-5 years, depending on regulatory approvals and market dynamics.
Q3: How does the market for chemotherapies like carmustine compare to immunotherapies?
Chemotherapies like carmustine have smaller market sizes but stable, established demand, unlike newer immunotherapies with rapid growth but higher prices.
Q4: What are the key challenges for maintaining current pricing levels?
Patent expiration, market entry of biosimilars, and healthcare reforms aimed at lowering drug costs.
Q5: How do reimbursement policies impact net prices for providers?
Reimbursement rates often reduce the effective price paid by hospitals, impacting overall revenue and pricing strategies.
References
[1] U.S. Food and Drug Administration. (2022). Biological Product Labeling. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=183633
