Last updated: July 29, 2025
Introduction
The drug with NDC 76204-0600 corresponds to Cytarabine Injection, a chemotherapeutic agent primarily used in the treatment of acute myeloid leukemia (AML), non-Hodgkin’s lymphoma, and other hematological malignancies. As an established oncology medication, its market dynamics are influenced by factors such as patent status, FDA regulations, competition, off-label uses, and emerging therapeutic alternatives. This analysis evaluates current market conditions, competitive landscape, pricing trends, and future price projections for this specific NDC.
Market Landscape
Product Profile and Indications
Cytarabine (Ara-C) is a cytidine nucleoside analog that inhibits DNA synthesis, inducing cell death in rapidly dividing cells. Its injectable form, designated under NDC 76204-0600, is typically administered intravenously in hospital and infusion center settings. The drug remains a cornerstone in AML treatment protocols, often used in combination regimens such as “7+3” (cytarabine plus anthracycline).
Market Size and Demand Drivers
The global AML market was valued at approximately USD 1.4 billion in 2022, with chemotherapy agents comprising a significant portion (Source: MarketsandMarkets). The US market alone accounts for roughly 30% of this figure, driven by a rising incidence of AML among older adults and increased adoption of intensive chemotherapy protocols.
Demand for cytarabine injections remains steady, particularly due to their role in frontline therapies. However, the increasing availability of targeted therapies and immunotherapeutic agents, such as FLT3 or IDH inhibitors, influences the growth trajectory of traditional chemotherapies.
Manufacturers and Supply Chain
Major manufacturers of cytarabine products include Teva Pharmaceuticals, Pfizer, and Hospira (a Walgreens Boots Alliance subsidiary). These companies supply both branded and generic versions, with a significant portion of the market comprised of generic drugs, which exert downward pressure on prices.
Supply chain considerations are stable, although raw material costs (notably, cytidine derivatives and manufacturing inputs) can impact pricing and margins. Additionally, manufacturing capacity constraints are minimal given the mature production process.
Competitive Dynamics
Generic Market and Price Competition
Generic cytarabine injections dominate the market, contributing to price suppression. The widespread availability of bioequivalent products ensures competitive pricing, which is essential for institutional procurement and insurance coverage negotiations.
Emerging Therapeutic Alternatives
Recent advances in targeted therapies, such as venetoclax-based regimens and other novel agents, gradually challenge traditional cytarabine-based therapy. While these are not direct substitutes, their increasing use can influence demand and pricing for cytarabine in specific patient populations.
Regulatory Environment
No recent patent exclusivities exist for cytarabine, confirming its status as a generic-ready compound. Regulatory pathways favor parallel importing and compounding, further limiting premium pricing opportunities.
Pricing Trends and Projections
Historical Price Trends
- Acquisition Cost: Historically, the average wholesale price (AWP) for cytarabine injections has ranged between USD 50–USD 150 per 1,000 mg vial, depending on manufacturer, formulation, and packaging (Source: Red Book and Medi-Span).
- Reimbursement Rates: Medicare and private insurers have maintained reimbursement levels aligned with these prices, with hospitals often negotiating further discounts through group purchasing organizations (GPOs).
Current Price Landscape (2023)
- Average Price: As of 2023, the median wholesale acquisition cost (WAC) for NDC 76204-0600 is approximately USD 70–USD 130 per 1,000 mg vial. Prices are subject to variation based on volume discounts, contractual arrangements, and regional factors.
- Discounting and Rebates: Hospital systems and bulk purchasers benefit from rebate programs and volume discounts, further compressing effective prices.
Future Price Projections (2024–2028)
- Downward Pressure: Continued generic competition and healthcare cost containment initiatives are expected to keep prices flat or declining modestly, at a compounded annual rate (CAR) of 1–3%.
- Market Entry of Biosimilars/Alternatives: Though biosimilar cytarabine products are not currently available, regulatory pathways could open this market segment, potentially decreasing prices further by 2025–2026.
- Impact of Treatment Paradigm Shifts: As targeted and immunotherapies gain prominence, demand for traditional cytarabine may plateau or decline, exerting further downward pressure on pricing.
Regulatory and Market Risks
- Regulatory Changes: Potential policy shifts favoring value-based pricing or incentivizing novel therapies could impact the traditional price trajectory.
- Supply Chain Disruptions: Material shortages or manufacturing disruptions could temporarily affect supply and pricing.
- Market Consolidation: Mergers among generic manufacturers might lead to price stabilization or increased bargaining power for some entities.
Conclusion and Strategic Insights
- The market for cytarabine injection (NDC 76204-0600) remains mature, with steady demand primarily driven by AML treatment protocols.
- Competitive pressures from generics and alternative therapies are likely to sustain a downward or stable pricing environment through 2028.
- Price erosion is expected at a modest rate, with potential for further reductions if biosimilars or novel delivery mechanisms enter the market.
Business stakeholders should focus on efficient procurement strategies, monitor regulatory developments, and anticipate evolving treatment algorithms that could influence demand and pricing dynamics.
Key Takeaways
- The cytarabine injection market is characterized by high generic competition, keeping prices modest.
- Current wholesale prices hover around USD 70–USD 130 per 1,000 mg vial; marginal declines are projected annually.
- Advancements in targeted therapies may supplement or supplant traditional cytarabine use, influencing future demand.
- Supply chain stability minimizes risks of price volatility, but potential biosimilar entrants could accelerate value compression.
- Strategic positioning involves leveraging volume discounts and staying abreast of regulatory shifts impacting pricing and reimbursement.
FAQs
1. How does generic competition influence prices for NDC 76204-0600?
Generic competition exerts significant downward pressure on prices, leading to stabilized or declining wholesale acquisition costs due to multiple manufacturers offering bioequivalent products.
2. Are there prospects for biosimilar cytarabine products?
Currently, biosimilars for cytarabine are not available; however, regulatory pathways could facilitate their development by 2025–2026, potentially lowering prices further.
3. What factors could alter future price projections?
Introduction of new therapies, regulatory changes favoring value-based pricing, manufacturing disruptions, and market consolidation are key factors influencing future prices.
4. How does reimbursement impact the effective price paid by healthcare providers?
Insurance negotiations, rebates, and formulary placements determine the net price, often resulting in lower effective costs than the listed wholesale prices.
5. What strategies can stakeholders use to optimize procurement?
Engaging with GPOs, negotiating volume-based discounts, and continuously monitoring market trends are critical to securing favorable pricing.
References
- MarketsandMarkets. Acute Myeloid Leukemia Market Report. 2022.
- Red Book Online. Pharmaceutical Pricing Data. 2023.
- Medi-Span. Drug Pricing and Reimbursement Insights. 2023.
- CMS. Medicare Part B Drug Pricing and Reimbursement Details. 2022.
- FDA. Regulatory pathways for biosimilar development. 2022.
