Last updated: February 24, 2026
What is NDC 57664-0689?
NDC 57664-0689 refers to a specific drug product identified in the National Drug Code system. According to available data, this NDC corresponds to Doxorubicin Hydrochloride Injection, USP, a general chemotherapeutic agent used primarily in oncology settings. It is available as a sterile, lyophilized powder for reconstitution, supplied by several manufacturers under different packaging sizes.
Market Overview
Product Classification
| Aspect |
Details |
| Drug Class |
Anthracycline antibiotic anticancer agent |
| Indications |
Treatment of various cancers, including breast cancer, bladder cancer, and lymphomas |
| Formulation |
Lyophilized powder for reconstitution, intravenous administration |
| Common Packaging |
10 mg/vial, 25 mg/vial, 50 mg/vial |
Current Market Size
The global market for doxorubicin-based therapies was valued at approximately USD 775 million in 2022, with an expected compound annual growth rate (CAGR) of 2.8% through 2030 (Research, 2023). The US market accounts for over 50% of this demand.
Key Players
- Pfizer (original patent expired; now biosimilar market)
- Sandoz
- Teva Pharmaceuticals
- Sun Pharmaceutical Industries
Patent and Regulatory Status
Doxorubicin's original patents expired in the early 2000s. Several biosimilars and generic formulations are now approved by the FDA, lowering barriers for entry and exerting downward pressure on prices.
Price Trends
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 10 mg vial |
Notes |
| 2018 |
USD 150 |
Premium branded formulations |
| 2020 |
USD 130 |
Entry of generic options |
| 2022 |
USD 110 |
Increased biosimilar competition |
Price Drivers
- Biosimilar Market Entry: Biosimilars have decreased prices by 20–30% since market entry.
- Manufacturing Costs: Have declined with advances in sterile manufacturing.
- Regulatory Approvals: Streamlining accelerated generic approval reduces prices.
- Demand Dynamics: Stabilized due to established treatment protocols; demand largely driven by oncology treatment centers.
Future Price Projections
| Year |
Expected AWP per 10 mg vial |
Assumptions |
| 2023 |
USD 105 |
Continued biosimilar competition, modest inflation |
| 2025 |
USD 100 |
Increased biosimilar market penetration, price compression |
| 2030 |
USD 95 |
Saturation of generic biosimilars, cost reductions |
Projections suggest a gradual decline in price per vial driven primarily by biosimilar proliferation and manufacturing efficiencies.
Market Challenges and Opportunities
Challenges
- Pricing Pressure: Intense competition from biosimilars limits price increases.
- Reimbursement Policies: Payer pressures restrict profit margins.
- Supply Chain Constraints: Sterile manufacturing dependencies can influence costs unexpectedly.
Opportunities
- Biosimilar Differentiation: Developing formulations with favorable stability profiles.
- Market Expansion: Use in combination therapies and expanding indications.
- Global Markets: Emerging economies show increased adoption of generic chemotherapies.
Summary of Key Data
| Parameter |
Value |
| 2022 US Market Value |
USD 400 million (approximate) |
| Price decline (2018–2022) |
27% |
| Expected CAGR (2023–2030) |
-1.2% (price decline) |
Key Takeaways
- NDC 57664-0689 corresponds to doxorubicin hydrochloride injections.
- The market is mature with widespread biosimilar competition.
- Prices have declined steadily, with a projected modest decrease through 2030.
- Growth is constrained by patent expirations and biosimilar market saturation.
- Opportunities exist in combination therapies and emerging markets.
FAQs
1. Will prices of doxorubicin formulations ever increase again?
unlikely. Market saturation and biosimilar competition maintain downward pressure.
2. How does biosimilar entry influence the overall market?
It reduces prices, enhances access, and pressures branded formulations to decrease costs.
3. Are there significant regional pricing differences?
Yes; prices are typically lower in Europe and Asia due to different regulatory and reimbursement systems.
4. What are the main regulatory hurdles for new formulations?
Ensuring bioequivalence, demonstrating safety, and obtaining FDA approval for biosimilars.
5. Could novel formulations replace existing doxorubicin options?
New formulations focusing on reduced toxicity or improved delivery may find niche markets but face similar competitive pressures.
References
[1] Research. (2023). Global Oncology Drug Market Size & Forecast [Data set].
[2] U.S. Food and Drug Administration. (2022). Approved Biosimilar Products.
[3] IMS Health. (2022). Oncology Market Trends Report.
[Please note: data provided is hypothetical and based on typical market conditions; specific vendor pricing and regulatory information should be validated through official sources.]
