Last updated: February 25, 2026
What is NDC 54738-0116?
NDC 54738-0116 corresponds to Karydisa (generic: Doxorubicin Hydrochloride), a chemotherapy drug used to treat various cancers, including leukemia, lymphoma, and breast cancer. It belongs to the anthracycline class of antineoplastic agents.
Market Overview
Current Market Size
The global oncology pharmaceutical market was valued at approximately USD 150 billion in 2022. Doxorubicin remains a foundational agent in chemotherapy regimens. In the U.S., approximately 1.2 million new cancer cases are diagnosed annually, with about 60% receiving chemotherapy involving agents like doxorubicin.
Market Share
Doxorubicin accounts for roughly 12% of chemotherapy agents used in the U.S. and Europe. The drug's market size is driven by:
- Cancer prevalence: Increasing incidence of breast, lung, and hematological cancers.
- Treatment protocols: Continued inclusion in combination therapies.
- Patent status: It is off patent globally, leading to generic competition.
Competition and Product Landscape
Generic versions dominate, with multiple manufacturers offering formulations. Key global players include:
- Pfizer (original patent holder, now off patent)
- Teva Pharmaceuticals
- Sandoz (Novartis)
- Mylan (now part of Viatris)
Biotech and specialty firms are exploring liposomal formulations, which could command premium pricing.
Pricing Analysis
Current Price Range
Wholesale Acquisition Cost (WAC) for doxorubicin (including NDC 54738-0116) is approximately USD 70–USD 150 per vial (10 mg/10 mL or 50 mg/10 mL).
The average retail price (Average Wholesale Price or AWP) can range from USD 120–USD 220 per vial depending on dosage and formulation. Hospital and specialty pharmacies often negotiate discounts totaling 20–30%.
Formulation Variations
- Standard formulations: 50 mg vials typical.
- Liposomal formulations: Marketed by Alnylam and others at prices exceeding USD 300–USD 400 per dose, significantly higher due to improved pharmacokinetics and reduced toxicity.
Price Trends
- Prices for generic doxorubicin have declined by approximately 15% over the last three years.
- Liposomal formulations have generally increased in price by 10–15% annually.
Regulatory and Policy Factors
- The drug is off patent globally, leading to increased competition.
- Some jurisdictions (e.g., U.S., EU) have policies to encourage biosimilar and generic use, potentially lowering prices.
- Potential shortages due to manufacturing issues can temporarily spike prices.
Market Potential and Price Projections
Short-term Outlook (1–2 years)
- Price stability or slight decline due to generic competition.
- Industry consensus indicates potential price drops of 5–10% driven by cost-saving healthcare policies.
- Liposomal formulations may sustain higher prices; expected to rise by 3–5% annually due to patent expirations on innovator products.
Mid- to Long-term Outlook (3–5 years)
- Entry of biosimilars or more advanced formulations could exert downward pressure, reducing prices by roughly 10–20%.
- Liposomal and targeted delivery platforms will likely command premium prices, maintaining a bifurcated market.
- Increased adoption in emerging markets could create volume-driven sales, potentially offsetting lower unit prices.
Revenue Projections
Assuming global annual sales reach USD 300 million, with 70% from generic formulations and 30% from liposomal variants, the total market could grow to USD 350–USD 400 million by 2027, influenced by volume increases and new indications.
Conclusion
The NDC 54738-0116 drug market is characterized by mature, competitive generic segments and emerging premium formulations. Price declines are expected due to intense competition, but innovative formulations may sustain or elevate prices. Market growth hinges on the increasing global cancer burden and adoption of advanced drug delivery platforms.
Key Takeaways
- NDC 54738-0116 pertains to doxorubicin, a widely used chemotherapy agent.
- The market is highly competitive with multiple generics, leading to declining prices.
- Liposomal formulations and delivery innovations maintain elevated price points.
- Short-term prices are expected to decrease slightly; long-term prices may stabilize due to innovation.
- Global cancer incidence growth will influence overall sales volumes.
FAQs
1. Will the price of doxorubicin increase or decrease in the next five years?
Prices for standard formulations are likely to decline 10–20% due to generic competition, while liposomal and innovative formats may sustain or slightly increase in price.
2. What factors most influence doxorubicin prices?
Market saturation with generics, manufacturing costs, regulatory policies, and new delivery technologies impact prices significantly.
3. How does the availability of biosimilars affect the market?
While biosimilars primarily target biologic products, their entry can indirectly lower prices for small-molecule agents like doxorubicin, increasing price competition.
4. Are there notable patent protections or exclusivities on versions of doxorubicin?
No, doxorubicin's patents have expired globally, enabling widespread generic manufacturing.
5. What emerging formulations could impact the market?
Liposomal doxorubicin and antibody-drug conjugates (ADCs) with similar active substances could capture higher price points due to improved efficacy and safety profiles.
References
- MarketsandMarkets. (2022). Oncology Drugs Market. Retrieved from https://www.marketsandmarkets.com/
- IQVIA. (2023). Global Oncology Market Analysis. Available through proprietary subscription.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling Data.
- PhRMA. (2022). The Biology of Biosimilars and Impact on Market Dynamics.
- WHO. (2021). Cancer Statistics and Projected Trends.
