Last updated: February 23, 2026
What is NDC 00574-1104?
NDC 00574-1104 is the National Drug Code for Doxorubicin Hydrochloride for Injection, USP (referred to as doxorubicin). It is an anthracycline antibiotic used primarily in chemotherapy for various cancers, including breast cancer, ovarian cancer, and Hodgkin’s lymphoma.
Market Overview
Market Size and Demand Drivers
- Global Oncology Drug Market (2022): Valued at approximately $157 billion, expected to reach $340 billion by 2030, with a compound annual growth rate (CAGR) of 9.4% [1].
- Doxorubicin: Accounts for an estimated 12% of chemotherapy drug sales globally. Sales are driven by:
- Rising cancer incidence rates, especially breast, lung, and hematologic cancers.
- Established efficacy and inclusion in standard chemotherapy protocols.
- Patent expirations and generic availability increasing accessibility.
- Market Penetration: Predominantly supplied by generic manufacturers, with limited remaining patent protections for branded versions.
Competitive Landscape
- Major Manufacturers (Generics):
- Hikma Pharmaceuticals
- Teva Pharmaceuticals
- Sandoz (Novartis)
- Sun Pharmaceutical
- Branded Versions: Less prevalent; primarily used in treatment protocols requiring specific formulations.
Regulatory Environment
- FDA Status: Approved for multiple indications.
- Patent Expiration: The original patent expired over a decade ago, with multiple generics now available.
- Pricing Regulations: Pricing varies across regions, heavily influenced by market competition, healthcare regulations, and negotiated reimbursement prices.
Price Analysis
Historical Pricing Data (U.S., 2020-2022)
| Year |
Average Price per Vial (100 mg) |
| 2020 |
$210 |
| 2021 |
$185 |
| 2022 |
$170 |
- Trend: Prices declined by approximately 19% from 2020 to 2022 due to increased generic competition.
Current Pricing Factors
- Standard Dose Vial: 50 mg to 100 mg doses.
- Price Range (2023): $150 to $200 per 100 mg vial, varies by supplier and healthcare payer negotiations.
- Reimbursement: Often based on institutional contracts or insurance policies, affecting effective market prices.
Pricing Influences
- Generic Competition: Continuously drives prices downward.
- Supply Chain Disruptions: Affect pricing temporarily, especially during global disruptions such as the COVID-19 pandemic.
- Regulatory Approvals: Introduction of biosimilars or new formulations can influence prices.
Price Projections (2023-2027)
| Year |
Projected Price per Vial (100 mg) |
Notes |
| 2023 |
$150 – $170 |
Mild decline due to saturated generic market |
| 2024 |
$140 – $165 |
Competitive pressures persist |
| 2025 |
$130 – $155 |
Possible stabilization at lower price points |
| 2026 |
$125 – $150 |
Market saturation continues |
| 2027 |
$120 – $145 |
Marginal declines expected |
Assumptions
- Competitive pressures from biosimilars, if approved.
- Sustained demand driven by cancer prevalence.
- No significant regulatory, clinical, or supply disruptions.
- Price erosion continues but stabilizes at lower levels due to fixed manufacturing costs.
Market Risks and Opportunities
Risks
- Supply Chain Disruptions: Affect availability and pricing.
- Regulatory Changes: New restrictions or approvals of biosimilars could decrease prices.
- Pricing Pressure: Payers’ push for lower costs could lead to further discounts.
Opportunities
- Emergence of Biosimilars: Expected to reduce prices further, increasing access but limiting revenue growth for existing suppliers.
- Expanding Indications: Approval for new cancer types or combined therapies could increase demand.
- Regional Expansion: Growing markets in Asia-Pacific, Latin America, and the Middle East.
Key Takeaways
- NDC 00574-1104, covering doxorubicin hydrochloride, is a mature, commoditized oncology drug.
- Market size is driven by global cancer treatment needs, with a significant share held by generics.
- Prices have declined over recent years, with a projection for continued gradual decrease.
- Future dynamics are shaped by biosimilar entry, regulatory policies, and cancer epidemiology.
- Prices in 2023 are expected to remain within $150-$170 per 100 mg vial, with slight downward trends continuing through 2027.
FAQs
1. How does biosimilar competition influence doxorubicin prices?
Biosimilars typically enter the market 8-12 years post-originator approval, reducing prices through competition. Their presence could further decrease prices by 10-25%, depending on regional regulations and acceptance.
2. Are there regional price differences for NDC 00574-1104?
Yes. Prices in the U.S. are generally higher due to reimbursement structures and regulatory policies, whereas emerging markets often see lower prices due to increased competition and cost controls.
3. What are the main indications for doxorubicin?
Doxorubicin is approved for breast cancer, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, leukemia, and ovarian cancer, among others.
4. How might future cancer treatment developments affect the patent landscape?
Emergence of targeted therapies and immunotherapies could reduce reliance on traditional chemotherapeutics like doxorubicin, potentially impacting demand and pricing.
5. What pricing strategies do manufacturers employ?
Manufacturers adjust prices based on market competition, procurement negotiations, supply chain costs, and regional policies.
References
[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/oncology-drugs-market
