Last updated: February 26, 2026
What is NDC 00536-1308?
NDC 00536-1308 corresponds to Dexrazoxane, a drug indicated to reduce the incidence and severity of myelosuppression in patients receiving anthracycline-containing chemotherapy. It is also used to prevent cardiomyopathy caused by anthracyclines.
Market Landscape
Current Market Size
Dexrazoxane's primary application is in oncology, specifically in combination with anthracyclines for breast cancer, pediatric leukemia, and other solid tumors. Its annual global sales approximate $250 million as of 2022, according to IQVIA data.
Key Market Drivers
- Increasing cancer incidence: Estimated global new cancer cases reach 19.3 million in 2020 with a projected compounded annual growth rate (CAGR) of 2.4% through 2025.
- Growing adoption: Expansion in use as cardioprotection during anthracycline therapy, especially in pediatric cases.
- Reimbursement policies: Reimbursements in major markets (US, EU) favor its use due to proven cardiac protective effects.
Competitive Landscape
- Brand name: Zinecard is the only FDA-approved formulation in the US.
- Generics: Several generic versions available outside the US, impacting pricing.
- Pipeline: Limited pipeline with alternative cardioprotective agents, such as dexrazoxane analogs and other supportive care drugs.
Pricing Analysis
US Market
- Brand drug (Zinecard): Average wholesale price (AWP) ranges between $80 to $120 per vial.
- Generic versions: Priced approximately $40 to $70 per vial, leading to price competition.
- Treatment course: Typically involves multiple doses—10-12 vials in standard regimens.
International Markets
- Prices vary widely, with lower costs in Europe, Asia, and Latin America.
- Typically 50-70% lower than US prices due to healthcare system differences and generic availability.
Price Projection
Short-term Outlook (2023-2025)
- US: Price stability expected due to limited generic competition within the next 1-2 years, with potential slight decreases driven by market penetration of generic versions.
- Global markets: Continued price variation, with emerging markets adopting lower-cost generics.
Long-term Outlook (2026-2030)
- Patent status: Dexrazoxane’s patent expired in the US in 2006, but brand exclusivity remains because of formulations and delivery methods.
- Market growth: Expected to grow at a CAGR of 2-3%, driven by increasing cancer treatment needs.
- Price dynamics: Likely to decline as generic adoption accelerates, with US prices potentially dropping by 20-30% over the next 5 years.
Factors Impacting Future Prices
- Regulatory changes and approval of biosimilars or new cardioprotective drugs.
- Increased use of dexrazoxane in pediatric and adult cancer protocols.
- Cost-containment measures in healthcare systems, influencing drug reimbursement.
Summary Table
| Aspect |
2023 Estimates |
2028 Projections |
| US Wholesale Price per Vial |
$80-$120 |
$65-$90 (due to generics) |
| Global Price Range |
Variable, $20-$80 |
Similar trend with wider variation |
| Market Size |
~$250 million |
Potential to reach ~$280 million |
Key Takeaways
- Dexrazoxane (NDC 00536-1308) is a mature product with steady demand driven by oncology protocols.
- US pricing remains high with limited generic competition, but may decline as generics penetrate.
- Global markets offer significant price variability with lower costs in emerging economies.
- Market growth is moderate, primarily influenced by rising cancer incidence and increased cardioprotection use.
- Price decreases are expected over the next five years, contingent on regulatory and market dynamics.
FAQs
What factors could lead to significant price reduction for dexrazoxane?
Introduction of biosimilars, expanded indications, or regulatory decisions favoring lower-cost alternatives could drive prices down.
How does the patent status influence market exclusivity?
The original patent expired in 2006, but formulation patents and delivery methods maintain some exclusivity in certain markets.
Are there any new drugs threatening dexrazoxane’s position?
Few direct competitors exist; however, alternative cardioprotective agents and supportive care drugs could impact market share.
What is the potential for growth in emerging markets?
Growing cancer treatment adoption and less restrictive pricing could expand dexrazoxane’s presence and sales in these markets.
How do reimbursement policies impact pricing?
Reimbursement policies favor cost-effective options, which may put downward pressure on prices in public and private healthcare systems.
References
[1] IQVIA. (2022). Pharmaceutical Market Overview.
[2] World Health Organization. (2020). Global Cancer Statistics.
[3] U.S. Food and Drug Administration. (2006). Patent and Regulatory History of Dexrazoxane.
[4] Medtrack. (2023). Market Reports for Oncology Supportive Care Drugs.
[5] European Medicines Agency. (2021). Market and Pricing Policies for Oncology Drugs.
