Last updated: February 21, 2026
What Is NDC 29300-0430?
NDC 29300-0430 refers to a prescription drug registered with the National Drug Code (NDC) directory. According to available data, this NDC belongs to Cytarabine Injection 100 mg/10 mL (10 mg/mL), a chemotherapeutic agent used for various hematologic cancers. The drug is marketed by Hikma Pharmaceuticals.
Market Size and Key Stakeholders
Indications and Usage
- Primary use: Treatment of acute myeloid leukemia (AML), lymphomas, and other hematologic malignancies.
- Administration: Intravenous infusion.
Patient Population
- Approximate annual incidence of AML in the U.S.: 20,000 cases.
- Population eligible for cytarabine therapy: 90%, considering response rates and contraindications.
Market Dynamics
| Factor |
Description |
| Market Penetration |
Limited to oncology clinics, hospitals, infusion centers. |
| Competition |
Other chemotherapeutic agents (e.g., daunorubicin, idarubicin). |
| Market Drivers |
Increasing leukemia incidence, expanding use in combination regimens. |
| Constraints |
High toxicity profile, outpatient usage limitations, regulatory hurdles. |
Key Competitors
- Pfizer (e.g., Cytarabine "Pfizer")
- Sanofi
- Teva Pharmaceuticals
Price Landscape and Trends
Current Pricing
| Price Point |
Approximate Wholesale Acquisition Cost (WAC) |
Notes |
| Per 100 mg vial |
$280 - $350 |
Varies by distributor, purchase volume. |
| Per 10 mL (100 mg) infusion |
$210 - $290 |
Packaging influences price. |
Historical Trends and Projections
- 2021: Prices ranged from $250 - $330 per vial WAC.
- 2022: Slight increase averaging 2-3% due to raw material costs and supply chain constraints.
- 2023: Anticipated stabilization with potential for a 1-2% decrease driven by generic competition and price negotiations.
Price Drivers
- Raw material costs, particularly cytarabine active pharmaceutical ingredient (API), influence manufacturing costs.
- Regulatory approvals for biosimilars or generics can lead to price erosion.
- Supply chain disruptions may cause temporary price increases.
Regulatory Environment and Impact on Pricing
- The drug has full FDA approval for AML and other indications.
- New biosimilar applications are under review; approval could impact pricing.
- Price caps or reimbursement policies from Medicare and Medicaid influence net pricing.
Market Prognosis
| Year |
Estimated Market Size (USD) |
Notes |
| 2023 |
$60 million |
Based on estimated patient volume and unit price. |
| 2024 |
$62 million |
Slight growth driven by increased AML diagnosis. |
| 2025 |
$65 million |
Market expansion in emerging markets; pipeline developments. |
Key Takeaways
- The market for cytarabine injection remains steady, with localized growth driven by higher leukemia diagnoses.
- Price points are relatively stable, with minor fluctuations influenced by manufacturing costs and competitive dynamics.
- Generic and biosimilar entries pose a significant risk to sustained pricing power.
- Regulatory policies and reimbursement trends exert ongoing influence.
FAQs
Q1: What factors could significantly alter the price of NDC 29300-0430?
Changes in patent status, introduction of biosimilars, supply chain disruptions, and shifts in regulatory policies.
Q2: How does competition influence the price?
Introduction of generics or biosimilars tends to lower wholesale prices, especially in established markets.
Q3: What is the outlook for demand in the next five years?
Demand is projected to grow modestly, driven by increased leukemia diagnoses and expanded treatment protocols.
Q4: Are there regional differences in pricing?
Yes. US prices are higher than those in Europe, partly due to differing healthcare reimbursement systems and market dynamics.
Q5: How do reimbursement policies impact net revenue?
Reimbursements at negotiated rates and coverage limits directly impact net sales, especially for hospitals and infusion centers.
References
[1] U.S. Food and Drug Administration. (2021). Cytarabine Injection - FDA label.
[2] IQVIA. (2023). National sales data and market estimates for oncology drugs.
[3] Medsource. (2023). Price analysis reports for chemotherapeutic agents.
[4] Clinical data from peer-reviewed journals on leukemia treatment trends.
[5] CMS. (2023). Medicare Part B coverage policies.
(Note: All data are approximate and based on current industry sources and available market reports as of 2023.)
