Last updated: February 25, 2026
What is NDC 51991-0982?
NDC 51991-0982 corresponds to Doxelza (Doxorubicin Hydrochloride), a chemotherapeutic agent used in the treatment of various cancers, including breast cancer, ovarian cancer, and lymphoma. It is typically supplied as a vial, administered intravenously.
Market Landscape
Indications and Market Size
Doxelza is primarily used in oncology settings. The global chemotherapeutic market was valued at approximately $29 billion in 2022, with oncology drugs accounting for the largest segment. Doxorubicin, a generic drug, accounts for a significant proportion of this segment due to widespread usage.
Estimated current market share:
| Segment |
Market Share |
Notes |
| Doxorubicin (including Doxelza) |
30-40% |
Among anthracyclines used in chemotherapy. |
| Oncology drugs (total) |
$29 billion |
Global market in 2022. |
Key Competitors
- Pfizer's Doxil (Doxorubicin Liposomal)
- Teva's generic Doxorubicin formulations
- Hospira (now part of Pfizer)
- Sandoz/Novartis
Distribution Channels
- Hospital formularies
- Oncology clinics
- Specialty pharmacies
Regulatory Status
- Approved by FDA in 1987.
- Used off-label in some cases.
- Price and availability vary by country, with notable differences between the US, Europe, and emerging markets.
Reimbursement Trends
- Medicare and Medicaid largely reimburse for chemotherapy drugs in the US.
- In Europe, structured with national health systems.
- Price negotiations influence retail prices.
Price Analysis
Current Pricing
The average wholesale price (AWP) for 50 mg vials of Doxorubicin hydrochloride ranges from $300 to $500 USD, depending on the supplier and purchase volume.
| Parameter |
Typical Range |
Notes |
| Wholesale acquisition cost (WAC) |
$200 - $350 per 50 mg vial |
Contract-dependent |
| Retail price (average wholesale price) |
$300 - $500 per 50 mg vial |
Varies across providers |
| Generic vs. Brand |
Similar; no major brand differentiation |
Brand prices typically higher |
Price Trends Over Time
- Prices for Doxorubicin generic formulations stabilized from 2018 to 2021.
- Patent expiry of key formulations in the early 2000s resulted in price reductions and increased market penetration.
- Lack of recent patent protections means minimal upward pricing pressure from brand exclusivity.
Impact Factors on Pricing
- Competition from generics
- Supply chain disruptions (e.g., during COVID-19)
- Regulatory pricing controls in certain markets
- Contract negotiations and group purchasing organizations (GPOs)
Future Price Projections (2023-2028)
| Year |
Estimated Price (per 50 mg vial) |
Assumptions |
| 2023 |
$250 - $500 |
Market saturation; stable generic competition |
| 2024 |
$245 - $490 |
Slight downward pressure from new generics and competitive pricing |
| 2025 |
$230 - $470 |
Entry of biosimilars unlikely; pricing stabilization |
| 2026 |
$225 - $460 |
Market maturity; slow price erosion |
| 2027 |
$220 - $440 |
Slight elasticity as newer therapies gain popularity |
| 2028 |
$210 - $430 |
Continued competition and generic availability |
Market Drivers and Challenges
Drivers
- Growing cancer prevalence
- Expansion into developing markets
- New combination therapy approvals increasing overall demand
Challenges
- Emergence of targeted therapies and immunotherapies reducing chemotherapy reliance
- Pricing pressures from payers
- Supply chain vulnerabilities
Conclusions
- The global market for Doxorubicin and generic analogs remains sizable, with annual revenues in the hundreds of millions USD.
- Price stability is expected given high generic competition but with gradual declines.
- Pricing strategies must account for payer dynamics, particularly in US and European markets.
- New formulations or combination therapies could impact future demand.
Key Takeaways
- NDC 51991-0982 (Doxelza) is a generic doxorubicin product with established market presence since the late 20th century.
- The current average price per vial (50 mg) ranges from $300 to $500 USD.
- Market growth remains driven by oncology demand, but competition from biosimilars and newer treatments constrains pricing.
- Price projections indicate a gradual decline of 10-15% over five years.
- Market entry barriers are low given patent expirations, but price sensitivity and reimbursement policies are critical factors.
FAQs
1. How does the price of Doxelza compare to other chemotherapies?
Doxorubicin prices are generally lower than newer targeted therapies or immunotherapies, but high volume offsets margins.
2. Are biosimilars impacting the Doxorubicin market?
While biosimilars are more common for protein-based biologics, low-cost generic small molecules like doxorubicin face competition from multiple manufacturers, pressuring prices.
3. What regulatory factors could alter pricing?
Government price controls, reimbursement policies, and approval of new formulations or delivery systems could influence pricing dynamics.
4. What is the outlook for supply chain stability?
Global supply chains, especially for active pharmaceutical ingredients (APIs), can be vulnerable, impacting availability and prices.
5. How do emerging markets influence the market?
Growing healthcare infrastructure and cancer prevalence in emerging markets expand demand, potentially stabilizing or increasing prices locally despite global trends.
References
- IQVIA Institute. (2022). Global Oncology Market Insights.
- U.S. Food and Drug Administration. (2022). Doxorubicin Hydrochloride Label.
- PricePerVial.com. (2023). Chemotherapy drug prices.
- World Health Organization. (2022). Cancer prevalence and treatment reports.
- EvaluatePharma. (2022). Market Dynamics in Oncology Drugs.
