Last updated: March 9, 2026
What is NDC 00245-5318?
NDC 00245-5318 refers to a specific drug product listed in the FDA’s National Drug Code directory. The product is identified as Doxorubicin Hydrochloride Injection, USP. This drug is used in chemotherapy for treating various cancers by intercalating DNA strands, inhibiting topoisomerase II enzyme, and inducing apoptosis.
Market Overview
Therapeutic Area and Competition
Doxorubicin is part of the anthracycline class of chemotherapies. Its primary indications include breast cancer, lymphoma, sarcoma, and other solid tumors. The market is highly competitive, with key players including Pfizer, Sandoz, and Teva.
Production and Distribution
Major manufacturers produce branded and generic versions. Branded formulations cost approximately $100–$150 per 50 mg vial, with generic versions priced between $70–$120 per vial.
Market Size
Based on recent data (IQVIA, 2022), the global chemotherapy drugs market was valued at approximately $14 billion. Doxorubicin’s share is estimated at 4-5% of this market, translating to an approximate market size of $600 million to $700 million in 2022.
Pricing Trends
Pricing varies by manufacturer, form (vial size), and healthcare setting. Hospital-based procurement is often at discounted rates due to bulk purchasing. Price increases over past five years have been moderate, averaging 3–5% annually.
Price Projections
Short-Term (Next 1–2 Years)
Medium to Long-Term (3–5 Years)
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Potential for slight declines in generic prices due to increased market competition and entry of new manufacturers.
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Orphan drug status or patent extensions may temporarily stabilize prices if applicable.
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Market saturation of biosimilar or alternative therapies could reduce demand, influencing price margins.
External Influences
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Reimbursement policies may affect final prices. Payor pressure can lead to increased discounts for hospital or pharmacy buyers.
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Regulatory changes impacting manufacturing costs or import/export tariffs could either increase or decrease prices.
Key Market Drivers
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Rising cancer incidence globally, especially in aging populations.
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Increasing use of combination chemotherapy protocols incorporating doxorubicin.
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Expansion into emerging markets with improved healthcare infrastructure.
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Development of biosimilars, which aim to reduce costs.
Competitive Landscape
| Manufacturer |
Product Name |
Price Range (per 50 mg vial) |
Market Share Est. |
| Pfizer |
Adriamycin |
$130–$150 |
60% |
| Sandoz |
Doxorubicin Sandoz |
$70–$100 |
20% |
| Teva |
Doxorubicin Teva |
$75–$110 |
15% |
| Others |
Various Generics |
$70–$120 |
5% |
Regulatory and Policy Impact
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The FDA has streamlined approval processes for biosimilars, which could increase competition.
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Cap and reduction policies for pricing on chemotherapy drugs could limit future price increases.
Summary
The market for NDC 00245-5318, primarily Doxorubicin Hydrochloride Injection, remains stable with modest price increases observed in recent years. Competition among generic manufacturers exerts downward pressure on prices, especially over the medium term. Short-term stability is driven by supply chain and regulatory factors. The market's growth is tied to increasing cancer rates and adoption of combination therapies.
Key Takeaways
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The current price range for the drug is $70–$150 per 50 mg vial, depending on manufacturer and setting.
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The market size exceeds $600 million globally, with anticipated steady demand.
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Price projections suggest minimal fluctuation over the next two years, with slight decreases possible due to competition.
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Factors such as biosimilar entry, regulatory changes, and healthcare policies will influence future pricing.
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Competition from biosimilars and generics will continue to exert downward pricing pressure.
FAQs
What factors most influence the drug’s price?
Manufacturers' production costs, competition, supply chain stability, and healthcare policies are primary influences. Reimbursement rates also shape final prices paid by providers.
How will biosimilar entry affect prices?
Biosimilars can reduce market prices by increasing competition, typically leading to a 20–30% price reduction for the original branded drug.
Are future price increases likely?
Limited by healthcare policy measures and market dynamics, future increases are unlikely beyond inflation-adjusted margins. Price decreases are more probable if new competitors enter the market.
What is the impact of regulations on this product?
Regulations can influence manufacturing costs, approval timelines, and market entry, impacting overall pricing and availability.
Is there potential for price increase due to new indications?
Yes, if expanded indications lead to increased demand and market exclusivity periods extend, prices may stabilize or slightly increase.
References
[1] IQVIA. (2022). Global Oncology Market Insights.
[2] FDA. (2022). National Drug Code Directory.
