Last updated: February 20, 2026
What Is the Drug Associated With NDC 00054-0382?
NDC 00054-0382 identifies a specific formulation of doxorubicin hydrochloride injection. Doxorubicin is an anthracycline antibiotic used mainly in cancer chemotherapy protocols, including breast cancer, sarcoma, and lymphoma.
Market Landscape
Current Market Size and Usage
- Global oncology drugs market was valued at $165 billion in 2022 [1]. Doxorubicin constitutes a significant share of the chemotherapy segment.
- Estimated annual sales for doxorubicin injectables in the U.S. reached approximately $500 million in 2022 [2].
- Doxorubicin is available as a branded product (e.g., Adriamycin) and through multiple generics.
Competition
| Product Type |
Examples |
Market Share |
Price Range (per mg) |
Notes |
| Branded |
Adriamycin (Pfizer) |
~60% |
$3.00 – $4.00 |
Preference in certain markets |
| Generic |
Multiple manufacturers |
~40% |
$1.50 – $2.50 |
Growing due to cost pressures |
Regulatory Status
- Approved by FDA since 1974.
- Available through generic manufacturers with varying supply agreements.
- No current FDA restrictions on manufacturing or distribution.
Price Projections
Historical Price Trends
- 2010–2020: Prices for doxorubicin ranged from $1.50 to $4.00 per mg, with branded products maintaining higher margins.
- 2021–2022: A decline in generic prices to approximately $1.50–$2.00 per mg due to increased competition.
Short-Term Forecast (Next 2 Years)
- Price stabilization expected at $1.80–$2.20 per mg as generic supply remains abundant.
- Potential price increase to $2.50 per mg if supply disruptions occur or if new patent-related restrictions arising in certain markets.
Long-Term Outlook (3–5 Years)
- Prices may decline marginally to $1.50–$2.00 per mg due to continued generic competition.
- Possible price increases if new indications or formulations are approved, or if supply chain issues affect availability.
- Market consolidation or manufacturing capacity changes could influence prices.
Factors Influencing Prices
- Patent expirations of key formulations.
- Regulatory changes allowing biosimilar or new formulations.
- Market demand driven by cancer prevalence and treatment protocols.
- Pricing policies in different countries, notably in emerging markets.
- Supply chain stability impacted by manufacturing capacity and raw material availability.
Key Considerations for Stakeholders
- Manufacturers should monitor patent statuses and regulatory approvals for biosimilars.
- Investors may anticipate stable or slightly declining prices over the next five years but should factor in increasing generic competition.
- Healthcare providers can expect pricing to favor generics but should verify supply stability.
Key Takeaways
- NDC 00054-0382 corresponds to doxorubicin hydrochloride injection.
- The drug operates within an established, competitive generic market.
- Prices have declined from a peak of around $4 per mg to current levels near $1.80–$2.20 per mg.
- Market dynamics suggest prices will stabilize around current levels or decline slightly unless supply constraints or regulatory changes occur.
- Ongoing patent expirations are likely to maintain competitive pricing pressures over the next five years.
FAQs
Q1: How does patent expiry affect doxorubicin pricing?
Patent expiry increases competition from generics, leading to price reductions.
Q2: Are biosimilars or new formulations expected to impact prices?
Biosimilars for doxorubicin are limited; new formulations could influence prices if approved and adopted.
Q3: How does regional regulation influence pricing?
Pricing varies significantly across countries, often lower in emerging markets due to regulatory policies and market competition.
Q4: What are the major risks to price stability?
Supply chain disruptions, manufacturing capacity constraints, or regulatory restrictions could cause price volatility.
Q5: How might COVID-19 have affected the supply or pricing of doxorubicin?
Disruptions in raw material supply and manufacturing delays during the pandemic temporarily affected availability but have largely stabilized.
References
[1] Markets and Markets. (2022). Oncology Drugs Market Report.
[2] IQVIA. (2022). National Sales Data for Oncology Injectables.
