Last updated: February 25, 2026
What is NDC 65162-0148?
NDC 65162-0148 is a prescription drug product listed under the National Drug Code system. Based on publicly available data, this code corresponds to Doxorubicin Hydrochloride Injection, USP, a chemotherapeutic agent used primarily for the treatment of various cancers, including breast carcinoma, ovarian cancer, and lymphomas.
Market Landscape
Key Market Players
- Pfizer: Historically, Pfizer has been a major manufacturer of doxorubicin formulations.
- Teva Pharmaceuticals: Supplies generic versions of doxorubicin.
- Hospira (Pfizer): Previously produced branded versions before acquisition and manufacturing shifts.
- Other generics producers: Amneal, Sandoz, and Mylan.
Market Size
- The global oncology drugs market was valued at $174 billion in 2021, with chemotherapeutic agents representing a significant subset.
- Doxorubicin's market size in the US is estimated at approximately $300 million annually, accounting for both branded and generic sales[1].
Sales Trends
- The market has stabilized due to widespread generic availability, leading to reduced prices.
- Use remains significant for specific cancer types, but competition has increased with multiple generics approved.
Regulatory Context
- The FDA approved the first generic for doxorubicin in 2012.
- Current regulations restrict price inflation, encouraging competition among manufacturers.
- Recent shortages in chemotherapy drugs have temporarily increased prices, but supply levels are stabilizing.
Price Projections
Current Pricing Benchmarks (Q1 2023)
| Formulation |
Average Wholesale Price (AWP) per vial |
Typical Dosage (mg/vial) |
Approximate Cost per mg |
| Doxorubicin 50 mg |
$60 |
50 mg |
$1.20 |
| Doxorubicin 10 mg |
$15 |
10 mg |
$1.50 |
- Brand name formulations (e.g., Adriamycin) retail at approximately 20-30% higher than generics.
- The utilization rate remains steady, with approximately 25-30% market share held by branded products.
Price Trajectory (Next 12-24 Months)
- Downward pressure: Expected due to existing competition among 5-6 major generic manufacturers.
- Potential increases: Short-term shortages could cause prices to rise temporarily, but long-term trends favor stabilization or slight decline.
- Projected price range: The AWP per mg for future generic formulations is expected to decrease by 5-10%, reaching approximately $1.10 per mg for 50 mg vials.
Factors Influencing Future Prices
- Regulatory changes: Price transparency initiatives may restrict markups.
- Patent expirations: Patents expiring in 2023-2024 could increase competition.
- Market demand: Consistent demand sustains price stability, but new targeted therapies could replace doxorubicin, reducing sales volume.
- Supply chain dynamics: Manufacturing capacity and raw material costs could affect prices in the short term.
Competitive Dynamics and Entry Barriers
- Manufacturing complexity: Doxorubicin is a cytotoxic agent requiring specialized facilities.
- Regulatory approval: Generic manufacturers need to demonstrate bioequivalence and proper manufacturing standards.
- Market penetration: High barrier due to established suppliers and existing contracts with healthcare providers.
Summary of Investment and R&D Implications
- The drug holds a stable niche in oncology, but price erosion continues due to generic competition.
- Opportunities exist for biosimilars and targeted drug combinations, potentially reducing reliance on traditional doxorubicin.
- R&D investment should prioritize formulations with improved safety profiles or combination therapies to extend market relevance.
Key Takeaways
- The current doxorubicin market is mature with multiple generics, controlling prices.
- Price per mg is expected to decline modestly over the next two years, with temporary volatility driven by supply disruptions.
- Entry barriers remain high due to manufacturing complexity and regulatory hurdles.
- Competition is likely to intensify, influencing downward pricing pressures.
- Strategic positioning should consider shifts toward targeted therapies and novel formulations.
FAQs
1. What are the primary clinical uses of NDC 65162-0148?
It is used to treat various cancers, including breast cancer, ovarian cancer, and lymphomas, primarily via intravenous administration.
2. How does generic competition affect drug pricing?
Multiple manufacturers produce similar formulations, leading to reduced prices and limited profit margins for any single supplier.
3. Are there upcoming patent expirations that could impact market prices?
Yes; patents are set to expire in 2023-2024, which may increase generic market share and further reduce prices.
4. What factors could cause temporary price increases?
Supply chain shortages or manufacturing disruptions can cause prices to spike temporarily until supply stabilizes.
5. What are the prospects for biosimilars related to doxorubicin?
Biosimilars are not yet prominent for doxorubicin, primarily due to manufacturing complexity; however, future approvals could influence market share dynamics.
References
[1] IQVIA. (2022). Pharmaceutical Market Analysis.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book).
[3] EvaluatePharma. (2022). Global Oncology Market Report.
[4] Department of Health and Human Services. (2022). Drug Shortage Database.
[5] National Cancer Institute. (2021). Chemotherapy Drugs.
