Last updated: February 16, 2026
What is the Drug?
NDC 00378-0137 is the generic version of Cytarabine (brand name: Cytosar-U), primarily used in chemotherapy for acute myeloid leukemia (AML), lymphomas, and other hematologic malignancies. It is available as an injectable solution.
Market Size and Demand
Incidence and Usage Data
- AML incidence: Approximately 20,000 new cases annually in the US (NCI [1])
- Cytarabine-based regimens dominate treatment protocols, with usage in about 70-80% of AML cases.
- Market penetration: Most marketed through hospital channels and infusion centers.
Key Market Players
- Pfizer: Original patent holder, now primarily generic.
- Teva, Sun Pharmaceutical, and other generics manufacturers: Significant producers and suppliers.
- Hospital formularies: Mainly used in inpatient settings, limiting outpatient sales.
Market Trends
- The rising incidence of AML increases potential demand.
- A shift toward outpatient chemotherapy may affect distribution channels.
- Drug price transparency initiatives may influence pricing strategies.
Current Pricing Landscape
Price Point of NDC 00378-0137
- Wholesale Acquisition Cost (WAC): Approx. $150 to $210 per 1,000 mg vial, depending on supplier.
- Average infusion dose per patient: 2,000 mg to 4,000 mg per cycle.
- Cost per treatment cycle: around $300 to $840, with variation based on dose and vial size.
Comparison with Brand
- Cytosar-U: Listed at approximately $600 to $900 per 1,000 mg at wholesale.
- The generic’s lower price undercuts brand pricing by 33-50%.
Price Trends
- Prices have stabilized over the past two years after a period of slight decline due to increased generic competition.
- Manufacturers face pressure to reduce costs amid hospital budget constraints and policy changes.
Regulatory and Market Dynamics
- The drug is off-patent; no exclusivity restrictions.
- New formulations, such as liposomal variants, could influence market share.
- Pricing control measures in the US and emerging markets may pressure prices downward.
Price Projections (Next 2-5 Years)
| Year |
Expected WAC Price Range |
Key Factors Influencing Price |
| 2023 |
$150 - $210 per 1,000 mg |
Stable generic competition, hospital procurement negotiating power |
| 2024 |
$140 - $200 |
Potential reimbursement reforms, increased generic penetration |
| 2025 |
$130 - $190 |
Cost pressures, possible entry of biosimilar-like generics in other markets |
Assumptions
- No major reformulation or patent litigation.
- No significant regulatory changes impacting manufacturing costs.
- Supply chain remains stable.
Risks and Opportunities
Risks
- Price erosion driven by commoditization of generic cytarabine.
- Policy reforms favoring drug cost containment.
- Market shrinkage if new therapies diminish the need for traditional cytarabine regimens.
Opportunities
- Expansion into emerging markets with less price regulation.
- Vertical integration in hospital supply chains to secure demand.
- Limited competition for niche formulations (e.g., preservative-free, liposomal).
Key Takeaways
- NDC 00378-0137 is a generic cytarabine injectable with a stable market presence.
- Current US WAC prices range from $150 to $210 per 1,000 mg.
- The market size is driven by AML incidence and chemotherapy protocols, primarily in inpatient settings.
- Prices are expected to decline modestly over the next five years amid competitive pressures and policy shifts.
- Opportunities exist in emerging markets and niche formulation segments.
FAQs
1. How does NDC 00378-0137 compare with other cytarabine formulations?
It is a standard generic injectable with a lower price than brand-name formulations. Liposomal or targeted formulations may command higher prices but serve different patient needs.
2. What factors could cause prices to decline more rapidly?
Increased competition, policy reforms targeting drug pricing, or the introduction of biosimilars could accelerate price decreases.
3. Can hospitals negotiate lower prices for this drug?
Yes, purchasing organizations, including group purchasing organizations (GPOs), often negotiate discounts that can lower effective costs below WAC.
4. How important is the patent status for this product?
Being off-patent, it faces no patent expirations or exclusivities, permitting multiple manufacturers and intense price competition.
5. Is there a potential for future demand growth?
Yes, as AML incidence increases, demand for cytarabine may grow, especially in regions with expanding healthcare infrastructure.
References
- National Cancer Institute. Cancer Stat Facts: Acute Myeloid Leukemia. 2022.
- Medicaid Drug Rebate Program. Pricing Trends in Oncology. 2022.
- IQVIA. Hospital and Clinic Oncology Sales Data. 2023.
- FDA Database. Approved Drug Listings. 2022.
