Last updated: February 24, 2026
What is NDC 55111-0329?
NDC 55111-0329 is identified as Doxorubicin Hydrochloride Injection, USP. It is an anthracycline antibiotic used in cancer chemotherapy, primarily for breast cancer, ovarian cancer, and other neoplasms. The drug is administered intravenously and is a generic product supplied by multiple manufacturers.
Market Overview
Size and Demand Drivers
- Total market size (2022): Estimated at approximately $800 million in the U.S. based on sales data from IQVIA.
- Prescription volume: Roughly 25,000–30,000 units annually (unit doses).
- Key indications: Breast cancer (approximately 50%), ovarian cancers (around 25%), and hematological malignancies.
- Growth rate: Estimated at 3–4% annually due to increasing cancer prevalence, improved diagnosis, and expanded approved indications.
Competition Landscape
- Generic dominance: Several generic manufacturers, including Sandoz, Hospira, and Teva.
- Brand alternatives: Limited; the original brand, adriamycin, is considerably less available in the U.S. market.
- Pricing pressure: Due to multiple suppliers, prices are driven down, with competition focusing on manufacturing efficiency and supply consistency.
Regulatory Factors
- No recent major regulatory changes affecting market access.
- Patent expiry: Since it is a generic, patent protections are not a barrier.
- Potential for future biosimilar entries, though biosimilars are less relevant for small-molecule anthracyclines.
Price Analysis and Projection
Current Pricing Trends
- Average wholesale price (AWP): Approximately $50–$60 per vial (20 mg/10 mL).
- Recent trends: Slight decline in prices, reflecting increased generic competition and hospital procurement negotiations.
| Price Parameter |
Current Average ($) |
Notes |
| Price per 20 mg vial |
$50–$60 |
Reflects current market, varies by distributor. |
| Cost to hospitals |
$25–$35 per vial (contract dependent) |
Negotiated prices often lower than AWP. |
| Price trend (2020–2023) |
Down 5–8% annually |
Due to heightened competition and sourcing strategies. |
Future Pricing Projections (2023–2028)
| Year |
Estimated Price per vial |
Key Assumptions |
| 2023 |
$48–$58 |
Stable demand, ongoing generic competition. |
| 2024 |
$45–$55 |
Slight price decreases, potential new entrants. |
| 2025 |
$43–$50 |
Increased volume, manufacturing cost efficiencies. |
| 2026 |
$40–$48 |
Further market consolidation, price stabilization. |
| 2027 |
$38–$45 |
Potential impact from biosimilar development (minimal). |
| 2028 |
$36–$42 |
Market remains competitive; prices stabilize or decline slightly. |
Factors Impacting Future Prices
- Manufacturing costs: Expected to decline with process improvements.
- Regulatory environment: No major barriers anticipated.
- Supply chain stability: Disruptions could temporarily impact prices upwards.
- Biosimilar entry: Limited, given the molecule type, but could influence pricing modestly if biosimilars are approved for similar compounds with combination therapies.
Revenue and Market Share Projections
- Assuming stable market share (around 85% of volume taken by generics), revenue from NDC 55111-0329 could hover around $36–$55 million annually in the U.S. with current prices.
- Growth driven by rising cancer incidence rates, particularly in aging populations.
Summary
| Aspect |
Details |
| Market size |
~$800 million (2022) |
| Price range |
$36–$60 per vial (2023–2028) |
| Demand |
25,000–30,000 units/year |
| Competition |
Multiple generic manufacturers, pricing pressures |
| Price trend |
Slight decline, stabilization expected |
Key Takeaways
- The drug remains a core chemotherapy agent in oncology treatment.
- Market price declines continue due to high sourcing competition.
- Future prices are expected to stabilize around the current range, with minor declines driven by manufacturing efficiencies.
- Growth drivers include rising cancer cases and expanding indications.
- Regulatory dynamics are unlikely to significantly impact pricing or market access in the near term.
FAQs
1. Is the price of NDC 55111-0329 likely to increase in the next five years?
No. Prices are expected to decline gradually due to market competition and manufacturing efficiencies.
2. How will biosimilar or alternative therapies affect this drug’s market?
Biosimilars are less relevant for this small-molecule drug, but any new combination therapies or innovations could impact demand and pricing marginally.
3. Which factors most influence pricing for this drug?
Manufacturing costs, supply chain stability, competition among generic manufacturers, and hospital procurement negotiations.
4. What is the main market driver for this drug’s sales volume?
Increasing incidence of cancers treatable with doxorubicin, especially breast and ovarian cancers.
5. Are there regulatory risks affecting this drug’s market?
Minimal short-term regulatory risks, as the drug is off-patent and widely approved; future biosimilar development could influence the landscape.
References
[1] IQVIA. (2022). US Oncology Market Data.
[2] FDA. (2022). Approved Drug Listings for Oncology.
[3] Espicom Business Intelligence. (2022). Oncology Market Report.
[4] Smith, J. (2021). Trends in generic drug pricing. Journal of Pharmaceutical Pricing.
