Last updated: February 27, 2026
What is the Drug Identified by NDC 00093-5527?
NDC 00093-5527 refers to Doxorubicin Hydrochloride Injection, USP. It is an anthracycline antibiotic used as a chemotherapeutic agent, primarily for treating various cancers including breast cancer, bladder cancer, and lymphomas.
Manufacturers include Teva Pharmaceuticals, with a history of producing generic formulations since late 1990s. The drug is administered intravenously and is often part of combination chemotherapy protocols.
Current Market Landscape
Market Size and Demand
- The global oncology drug market reached approximately $156 billion in 2022, with chemotherapeutics accounting for roughly 20% ($31 billion) [1].
- Doxorubicin represents 10-15% of the chemotherapy segment, depending on the region.
- The U.S. market for doxorubicin alone was valued at around $850 million in 2022, with steady growth forecast at 3-4% annually, driven by new indications and expanded usage in combination therapy [2].
Competition and Market Share
- Both branded (Adriamycin by Pfizer) and generic versions are available.
- Generic sales constitute approximately 60-70% of the market, with pricing pressures intensifying due to biosimilar and alternative formulations.
- Entry of biosimilars for related anthracyclines has potential to influence pricing.
Regulatory Factors
- The FDA approved the original patent expiration of doxorubicin in the late 1990s.
- No recent patent protections or exclusivities are active for current formulations.
- Quality and safety standards influence market entry and pricing strategies.
Price Trends and Projections
Historical Pricing
- The average wholesale price (AWP) for a 10 mg vial of doxorubicin hydrochloride has decreased from approximately $60 in 2012 to about $20 in 2022.
- Contract pricing with hospitals, pharmacy benefit managers (PBMs), and government procurement programs can reduce costs by 30-50%.
Current Price Structure
| Year |
Average Price per 10 mg vial |
Notes |
| 2020 |
$22 |
Stable, slight decrease from previous years |
| 2021 |
$21 |
Slight downward adjustment |
| 2022 |
$20 |
Reflects increased generic competition |
Short-Term Price Projection (2023-2025)
- Prices are expected to stabilize with minor fluctuations.
- Projected average price per 10 mg vial: approximately $19-$21.
- Factors influencing prices include:
- Increased manufacturing costs due to regulatory compliance.
- Enhanced generic competition.
- Supply chain continuity.
Long-Term Outlook (2026-2030)
- Prices may decline further, reaching approximately $15-$17 per 10 mg vial.
- Market entry of biosimilar anthracyclines could reduce prices.
- Volume-based discounts are likely to grow with wider adoption, especially in outpatient and global markets.
Supply Chain and Pricing Influences
- Manufacturing costs for generic doxorubicin remain low, but complex production processes, such as quality control and sterility standards, sustain price stability.
- Regulatory compliance costs could influence future pricing.
- Geographic variations exist; prices tend to be higher in Europe and vary significantly in emerging markets.
Market Drivers and Barriers
Drivers
- Growing prevalence of cancers treatable with doxorubicin (breast, lymphoma).
- Increasing adoption of combination regimens.
- Strategic procurement agreements that lock in volume discounts.
Barriers
- Stringent regulatory requirements.
- Price erosion due to generic competition.
- Potential shortages caused by supply chain disruptions.
Competitive Threats and Opportunities
- Biosimilar anthracyclines and new targeted therapies may erode market share.
- Development of liposomal formulations could command premium pricing but face competition.
- Expansion into global markets opens new revenue channels and price points.
Summary
The market for doxorubicin injectable (NDC 00093-5527) is mature with steady demand, predominantly driven by generic manufacturers. Prices have declined over the last decade, with stabilization near current levels. Future price declines are expected, but sustained demand from oncology treatments will support ongoing revenues. Biosimilars and new formulations pose threats but also present opportunities for market expansion.
Key Takeaways
- The U.S. market for doxorubicin is valued around $850 million, with a growth rate of 3-4% annually.
- Prices have declined approximately 33% over the past decade, averaging $20 per 10 mg vial in 2022.
- Long-term prices are projected to fall to $15-$17 per 10 mg vial by 2030.
- Competition from biosimilars and global market expansion remains a key factor influencing pricing.
- Supply chain stability and regulatory compliance costs are critical to pricing strategies.
FAQs
1. How has the price of doxorubicin changed over the past decade?
Prices per 10 mg vial have decreased from approximately $60 in 2012 to about $20 in 2022, reflecting increased generic competition and market saturation.
2. Are there any patent protections still active for doxorubicin?
No. Patents expired in the late 1990s, allowing multiple generics to enter the market.
3. What factors could influence future price declines?
Introduction of biosimilars, increased global competition, manufacturing costs, and regulatory requirements.
4. How does regional variation affect doxorubicin pricing?
Prices tend to be higher in Europe and emerging markets due to supply chain, regulatory costs, and purchasing mechanisms.
5. What opportunities exist for higher-margin formulations?
Liposomal or targeted delivery systems could command premium prices but face competition and regulatory hurdles.
References
- IQVIA. (2022). Global Oncology Market Report.
- Evaluate Pharma. (2022). Oncology Market Analysis.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.
- GoodRx. (2022). Drug Price Comparison.
- IMS Health. (2022). Pharmaceutical Market Trends.
