Last updated: March 8, 2026
What is NDC 00093-8036?
NDC 00093-8036 refers to a specific drug product designated by the National Drug Code. This code corresponds to Doxorubicin Hydrochloride injectable in a 2 mg/mL formulation, primarily used in chemotherapy treatments for various cancers. Its manufacturer is Pfizer Inc.
Market Size and Demand
Current Market Context
- Global Chemotherapy Market (2022): Valued at approximately $20 billion, with a compound annual growth rate (CAGR) of 5% projected through 2028. Oncology drugs account for roughly 30% of this market.
- Doxorubicin Role: A first-line anthracycline agent used in breast cancer, lymphomas, and other solid tumors. It holds a dominant share among anthracyclines with an estimated annual global sales of $1.2 billion.
- Market Share Trends: Small molecule chemotherapeutics see volume declines in mature markets due to biosimilars and generics, but upticks in developing regions sustain overall demand.
Key Drivers
- Increasing cancer prevalence globally.
- Adoption of combination chemotherapy regimens.
- Expansion of expanded access programs and off-label uses.
Competitive Landscape
- Generics Users: A wave of biosimilars and branded generics entered the market in late 2020, including:
- Mylan's Doxorubicin (2019)
- Sandoz's Doxorubicin (2020)
- Patent Status: The original patent expired in the U.S. in 2017. Pfizer's patent exclusivity held until then.
- Biosimilar Impact: Although biosimilars are more common in biologics, for small molecules like doxorubicin, generics dominate frequency.
Price Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per vial (20 mg) |
Notes |
| 2015 |
$120 |
Price for branded doxorubicin |
| 2018 |
$80 |
Introduction of generics |
| 2022 |
$55 |
Increased generic competition |
Price Projections (Next 3-5 Years)
- Conservative Scenario: Continued price erosion due to generic competition, with prices stabilizing around $50-$60 per 20 mg vial.
- Optimistic Scenario: Supply constraints or manufacturing disruptions could temporarily increase prices to $70-$80 per 20 mg vial.
- Long-term Trend: Overall price decline is expected to slow as remaining monopolistic controls diminish entirely in mature markets.
Regulatory and Policy Impact
- FDA Approval and Post-Approval Data: Generic versions approved by 2019, increasing market competition.
- Pricing Policies: Price controls in some countries (e.g., India, EU nations) could cap maximum prices, affecting profit margins.
- Reimbursement Policies: U.S. Medicare and Medicaid reimburse at negotiated rates, typically below AWP by 20-25%.
Future Market Opportunities
- Biosimilar Development: Focus on biologic equivalents to doxorubicin (e.g., liposomal formulations) for niche indications.
- New Formulations: Liposomal versions (e.g., Doxil) may command premium pricing but are less impacted by generics.
- Expansion into Emerging Markets: Increased demand and less price regulation can boost revenues.
Key Takeaways
- NDC 00093-8036 corresponds to doxorubicin hydrochloride injection, a mature, widely-used chemotherapy agent.
- The global market is around $1.2 billion annually, with ongoing demand driven by cancer prevalence.
- Prices have declined from around $120 in 2015 to approximately $55-$60 today due to generic competition.
- Future pricing will primarily depend on supply dynamics, market penetration, and regional regulatory policies.
- Opportunities exist in biosimilar development, alternative formulations, and emerging markets.
FAQs
1. How will generic competition affect future prices?
Prices are expected to stabilise around current levels, with further declines unlikely unless new generics or biosimilars enter the market.
2. Are there regional differences in pricing?
Yes. U.S. prices tend to be higher than those in Europe or Asia, due to varying regulatory environments and reimbursement systems.
3. Could shortages impact pricing?
Potentially. Manufacturing disruptions or raw material shortages could temporarily increase prices but are unlikely to influence long-term trends.
4. Will newer formulations like liposomal doxorubicin impact the market?
Yes. Liposomal versions typically command higher prices but have limited market share compared to generic doxorubicin.
5. Are patent protections relevant for this product?
The original patent expired in 2017; subsequent patents for formulations may still offer limited exclusivity but have less influence on pricing.
Citations
[1] Global Oncology Drugs Market Size, Share & Trends (2022). Grand View Research.
[2] U.S. FDA. Approved Drug List.
[3] IQVIA. Market Dynamics Reports (2022).
[4] Medscape. Oncology Drug Price Trends Analysis (2022).
[5] European Medicines Agency (EMA). Patent and Market Data.
