Last updated: February 21, 2026
What is NDC 51672-4038?
NDC 51672-4038 is a drug product approved by the FDA. Based on available data, it corresponds to Doxorubicin Hydrochloride Injection, USP. Doxorubicin is an anthracycline antibiotic used in chemotherapy for various cancers, including breast cancer, lymphoma, and leukemia.
Market Overview
Current Market Size and Trends
The global oncology drug market valued at $153 billion in 2022 is expected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030 [1]. Doxorubicin remains a standard chemotherapeutic agent, with an estimated annual US sales of approximately $200 million as of 2022 [2].
Key Market Players
Major manufacturers include:
- Pfizer Inc.
- Teva Pharmaceutical Industries Ltd.
- Sun Pharmaceutical Industries Ltd.
- Hikma Pharmaceuticals
The product’s market share is primarily driven by generic manufacturers and institutional purchasing.
Regulatory and Patent Status
Doxorubicin's patents expired in the early 2000s, resulting in widespread generic availability. Current regulatory considerations focus on manufacturing quality and biosimilarity in certain markets.
Price Trends and Projections
Historical Pricing Data
- April 2022: Price per vial (50mg) averaged $72.
- April 2023: Price decreased slightly, averaging $68.
- Variability exists based on supplier and formulation (e.g., branded vs. generic).
Current Pricing Factors
- Production costs for injectables are high due to sterile manufacturing.
- Regulatory compliance adds costs, especially in the US.
- Market liquidity hinges on hospital and oncology clinic purchasing.
Future Price Projections
Over the next 5 years, prices are expected to decline gradually due to increased generic competition and manufacturing efficiencies:
| Year |
Estimated Price per 50mg vial |
Key Factors |
| 2023 |
$68 |
Saturation of generic supply |
| 2024 |
$66 |
Regulatory tightening |
| 2025 |
$63 |
Market consolidation |
| 2026 |
$60 |
New biosimilar entrants |
| 2027 |
$58 |
Technological improvements in manufacturing |
Price Drivers
- Increased competition among generics will suppress prices.
- Price sensitivity will depend on hospital procurement practices.
- Potential biosimilar approvals could further reduce costs.
Risks and Limitations
- Price reductions could be offset by raw material cost increases.
- Supply chain disruptions (e.g., COVID-19 effects) may influence pricing.
- Regulatory changes could impact manufacturing costs or restrict product availability.
Strategic Implications
Investors and manufacturers should monitor:
- Biosimilar development pipelines targeting doxorubicin.
- Regulatory changes impacting injectable drug formulations.
- Trends in oncology treatment protocols affecting demand for doxorubicin.
Key Takeaways
- NDC 51672-4038 is identified as doxorubicin hydrochloride injection.
- The drug is mature in the US market, with widespread generic competition.
- Pricing has stabilized near $68 for a 50mg vial, with a downward trend forecasted.
- Price declines are driven by generic competition, biosimilar entry, and manufacturing efficiencies.
- Market access and procurement practices significantly influence pricing margins.
FAQs
1. What factors primarily influence the price of doxorubicin injectable?
Market competition, manufacturing costs, regulatory compliance, and hospital procurement strategies.
2. How soon could biosimilars affect prices?
Biosimilar candidates are in development stages; regulatory approval and market penetration could occur within 3-5 years, potentially reducing prices further.
3. Are there any recent regulatory actions impacting doxorubicin?
The FDA has maintained standard manufacturing oversight but has not introduced new regulations specific to doxorubicin since 2020.
4. What are the main markets for doxorubicin?
Primarily the US, EU, and Asia-Pacific regions, with the US representing over 50% of sales in recent years.
5. How does the price of NDC 51672-4038 compare to other chemotherapeutic agents?
It is comparable in price to other generic chemotherapies but slightly lower due to high competition and patent expiry.
References
[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends.
[2] IQVIA. (2022). US Oncology Market Data Report.
