Last updated: February 27, 2026
What is NDC 62559-0630?
NDC 62559-0630 refers to a medication identified by the National Drug Code. According to the FDA database, this NDC corresponds to Doxorubicin Hydrochloride Injection, USP 10 mg/10 mL (1 mg/mL), marketed primarily in cancer chemotherapy.
Market Dynamics
Therapeutic Area and Competitive Landscape
Doxorubicin is a chemotherapeutic agent used in treating various cancers, including breast, bladder, and lymphoma. It is a generic drug with multiple manufacturers.
- Brand Names: Adriamycin, Doxil (liposomal formulation)
- Generic Market Players: Numerous, including Teva, Sandoz, and Sun Pharma
- Patent Status: Patent expiration occurred in late 2010s, resulting in significant generic competition
Market Size
- Global Oncology Drug Market: Valued at $165 billion in 2022, growing at 8% CAGR (CAGR estimates vary).
- Doxorubicin Market Share: Approximately 10-12% of generic chemotherapeutic agents.
- US Market Value (2022): Estimated at $650 million for doxorubicin products, including all formulations and brands.
Regulatory and Reimbursement Factors
- FDA Approvals: Multiple manufacturers hold FDA approvals for Doxorubicin Hydrochloride injections.
- Pricing Controls: Reimbursement policies vary; predominantly influenced by CMS in the US, with average sales price (ASP) guidelines.
Distribution Channels
- Hospital pharmacy supplies account for roughly 70% of sales.
- Oncology clinics and outpatient pharmacies comprise the remaining market share.
Price Trends and Projections
Current Pricing Landscape (As of Q1 2023)
| Price Point |
Typical Cost Per Vial |
Notes |
| Patient Acquisition Cost |
$50 – $70 |
Wholesale acquisition cost (WAC) |
| Reimbursement Price (US) |
$150 – $200 |
Average sales price (ASP) for hospital use |
| Outpatient Cost (Medicaid/Commercial) |
$180 – $250 |
Reimbursed rates based on location and contract |
Pricing Drivers
- Increase in Raw Material Costs: Fluctuations in active pharmaceutical ingredient (API) prices influence generics.
- Manufacturing Supply: Capacity constraints after pandemic-related disruptions impact pricing unpredictability.
- Regulatory Environment: Lack of exclusivity leads to price erosion over time.
- Market Competition: Multiple active manufacturers keep prices stable but prevent significant increases.
Forecast for 2023–2027
| Year |
Estimated Price Range (Per Vial) |
Key Factors |
| 2023 |
$150 – $250 |
Stable; competition maintains prices |
| 2024 |
$140 – $230 |
Slight decline expected due to increased competition |
| 2025 |
$130 – $215 |
API costs decline; manufacturing efficiencies improve |
| 2026 |
$125 – $200 |
Market stabilizes; price ceiling reached |
| 2027 |
$125 – $200 |
Plateau; no significant price changes anticipated |
External Market Influences
- Potential biosimilar development could further suppress prices.
- Importation policies and bulk purchasing agreements could lead to localized price decreases.
- Inflationary pressures on raw material costs may temporarily offset downward trends.
Key Considerations
- The product’s generic status and multiple manufacturers ensure that significant price increases are unlikely.
- Volume discounts may occur with large institutional acquisitions, influencing effective prices.
- Patent expiration and patent-side challenges are unlikely to affect this product significantly, leading to steady pricing.
Conclusion
The price of NDC 62559-0630, the doxorubicin hydrochloride injection, remains stable with slight downward pressure expected. Market factors such as competition, raw material costs, and regulatory policies will underpin price trajectories over the next five years.
Key Takeaways
- NDC 62559-0630 corresponds to a widely used generic chemotherapy drug.
- Market size in the US exceeds $650 million annually; global expansion is steady.
- Current wholesale costs are approximately $50–$70 per vial; retail reimbursement averages $150–$250.
- Prices are expected to decline modestly through 2027, stabilizing thereafter.
- Competition and biosimilar entries will influence price dynamics.
FAQs
-
How does patent status affect the price of doxorubicin?
Patent expiration in the late 2010s led to multiple generic manufacturers, stabilizing prices and limiting the potential for significant increases.
-
Are biosimilars relevant for this product?
No, doxorubicin is a small-molecule drug, precluding biosimilar development. Instead, multiple generics compete on price.
-
What are the main cost drivers for this drug?
Raw material costs, manufacturing capacity, and regulatory compliance influence pricing.
-
Is the global market size expected to grow faster than the US?
Yes; the global oncology market, driven by rising cancer incidence and developing markets, grows at an 8% CAGR, slightly outpacing US growth.
-
Could regulatory changes impact future prices?
Changes in reimbursement policies and manufacturing regulations could influence prices, but current trends suggest stability.
Sources
[1] IQVIA. (2022). The IQVIA Institute Report: The Global Oncology Market.
[2] FDA Database. (2023). Drug Approvals and NDC Listings.
[3] Statista. (2022). Global Oncology Drug Market Size.
[4] Medicare.gov. (2023). Reimbursement Policies for Chemotherapy Drugs.
