Last updated: February 20, 2026
What is the Drug NDC 46122-0745?
NDC 46122-0745 corresponds to a specific formulation of a prescription drug. According to the FDA's NDC Directory, this code identifies Doxorubicin Hydrochloride Injection, USP, 50 mg. Doxorubicin is an anthracycline chemotherapeutic agent used primarily for treating various cancers including breast cancer, bladder cancer, and lymphomas.
Market Overview
Indications and Usage
Doxorubicin is a core component in many chemotherapy regimens. Its popularity remains high for oncology treatments, though its usage is constrained by toxicity profiles such as cardiotoxicity.[1]
Current Market Size
The global oncology drug market was valued at approximately $165 billion in 2022, with chemotherapeutic agents representing a significant segment.[2] Doxorubicin's share depends on clinical usage trends, patent status, and competitive off-patent generic options.
Competition Landscape
- Generic Availability: Doxorubicin formulations, including NDC 46122-0745, are widely available generics. Since the patent expired decades ago, multiple manufacturers produce similar formulations, driving downward price pressures.
- Market Players: Major suppliers include Pfizer, Sandoz, and Teva, among numerous generic companies.
- Emerging Trends: Biologics and targeted therapies are gradually replacing traditional chemotherapeutic agents in specific settings, potentially affecting demand volume.
Regulatory and Reimbursement Factors
- FDA approval: The drug is FDA-approved with no recent significant regulatory changes.
- Reimbursement: Primarily covered under Medicaid and private insurance, with reimbursements influenced by CMS pricing policies and negotiated discounts.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 50mg vial |
Notes |
| 2018 |
$150 |
Prevalence of newer agents |
| 2020 |
$130 |
Market saturation with generics |
| 2022 |
$125 |
Increased competition |
The price has declined to approximately $125 per 50mg vial as of 2022, reflecting commoditization of generic chemotherapy drugs.
Price Drivers
- Generic Competition: Increased supplier count reduces prices.
- Manufacturing Costs: Stable or slightly declining, driven by process efficiencies.
- Supply Chain Dynamics: Pandemic-related disruptions in 2020-2021 caused price volatility, but stabilization occurred by 2022.
- Reimbursement Policies: Potential reductions due to drug price negotiations at the federal level.
Short-term Price Projection (Next 2 Years)
- Prices are expected to remain in the range of $120-$125 per 50 mg vial.
- Slight downward pressure due to ongoing market saturation.
- Potential for minor increases if manufacturing costs increase or supply chain disruptions occur.
Long-term Price Projection (3-5 Years)
- Prices may stabilize further around $115-$120 if no new competitors enter and demand remains steady.
- If a biosimilar or alternative therapy gains approval and market share, prices could decrease further, possibly to below $110 per vial.
Factors that Could Alter Pricing Trends
- Introduction of biosimilars or reformulations.
- Changes in healthcare policy targeting drug price regulation.
- Supply chain disruptions or shortages.
- Accelerated adoption of emerging therapies reducing demand.
Strategic Implications
- For manufacturers: Margin pressures are substantial, calling for cost optimization.
- For healthcare providers: Price stability favors continued use, especially when alternatives are limited.
- For investors: The mature, highly competitive market suggests limited upside unless new formulations or indications emerge.
Summary Table: Price Trends Summary
| Timeframe |
Expected Price Range |
Key Influences |
| Next 2 years |
$120 - $125 |
Generic competition, stable manufacturing, supply chain stability |
| 3-5 years |
$115 - $120 |
Market saturation, no new entrants |
Key Takeaways
- NDC 46122-0745 is a generic doxorubicin hydrochloride injection with a low-cost, mature market.
- Prices have declined steadily over recent years, stabilizing around $125 per 50mg vial.
- Market pressures include generic competition, reimbursement policies, and emerging therapies.
- Future pricing likely remains stable with slight decreases unless disrupted by supply chain issues or new therapeutic entrants.
FAQs
1. Is NDC 46122-0745 a branded or generic drug?
It is a generic version of doxorubicin hydrochloride injection, widely available from multiple manufacturers.
2. How is the demand for doxorubicin expected to change?
Demand will likely remain steady in oncology, although increased use of targeted therapies may marginally impact volume.
3. What factors most influence the price of this drug?
Market competition, manufacturing costs, supply chain stability, and reimbursement policies.
4. Are biosimilars affecting the market for doxorubicin?
Biosimilars are more common in biologic drugs; since doxorubicin is a small molecule, biosimilar impact is limited but could increase with new formulations.
5. What is the outlook for pricing if a new, superior chemotherapeutic agent is approved?
Demand for doxorubicin could decline, pushing prices lower, especially if alternatives prove more effective or safer.
References
[1] U.S. Food and Drug Administration. (2022). Doxorubicin Hydrochloride Injection, USP. Retrieved from https://www.fda.gov
[2] MarketResearch.com. (2023). Global Oncology Drugs Market Report.
[3] IQVIA. (2022). U.S. Prescription Drug Price Index.
