Last updated: February 20, 2026
What is NDC 00310-0271?
NDC 00310-0271 refers to Doxorubicin Hydrochloride injection, a chemotherapeutic agent used primarily to treat various cancers, including ovarian, breast, bladder, and others. It is an on-patent drug, with several generic versions available.
Market Size and Trends
Current Market Landscape
The global oncology drug market was valued at approximately $165 billion in 2022, with chemotherapy agents comprising a significant subset. Doxorubicin remains a mainstay in cancer treatment protocols, cited by over 60% of chemotherapeutic regimens for solid tumors [1].
Competitive Environment
The market features multiple generic manufacturers due to patent expirations. Top suppliers include Pfizer, Teva, Sandoz, and local generics providers. Since the original patent expired in the early 2000s, multiple generics have entered the market, increasing competition and driving prices down.
Distribution Channels
Doxorubicin is supplied primarily through hospitals and oncology clinics. The drug is included in standard treatment protocols, leading to steady demand despite the emergence of newer therapies.
Regulatory Landscape
The FDA approves both brand and generic versions under the Abbreviated New Drug Application (ANDA) pathway. As of 2022, no recent major regulatory changes impact this drug’s approval status.
Price Analysis
Historical Pricing
The average Wholesale Acquisition Cost (WAC) for doxorubicin in the U.S. has seen a declining trend since 2010. On average, the price per 10 mL vial (notably 2 mg/mL concentration) was approximately $20–$25 in 2010, dropping to around $8–$12 in 2022 due to increased generics.
Current Price Range
| Attribute |
Estimated Price (2023) |
| Brand-name (e.g., Pfizer) |
$12–$15 per 10 mL vial |
| Generic versions |
$8–$12 per 10 mL vial |
Prices vary by supplier, purchase volume, and regional factors. Hospitals often engage in bulk purchasing agreements that can lower effective costs.
Price Projections (Next 5 Years)
Price trends are unlikely to decline significantly further, given the drug's established marketplace and limited innovation. However:
- Moderate stability in prices expected due to consistent demand.
- Potential slight increases in manufacturing costs could influence prices minimally.
- Market competition decreases with patent protections on newer formulations, maintaining pricing pressure on older drugs.
Impact of Biosimilars and New Therapies
Although biosimilars for doxorubicin are not yet prevalent, future approvals could influence prices:
- Emergence of biosimilars could lower prices by 10–20% over the next decade.
- New cancer therapies may reduce demand for doxorubicin, impacting volume and potentially prices.
Market Growth Drivers and Risks
Drivers
- Continued use in combination chemotherapy regimens.
- Licensing agreements in emerging markets.
- Expansion into development of liposomal formulations with differentiated efficacy.
Risks
- Competition from targeted or immunotherapy agents.
- Regulatory changes affecting manufacturing or distribution.
- Synchronization of treatment protocols shifting away from traditional chemotherapy.
Key Takeaways
- The current U.S. market price for NDC 00310-0271 ranges between $8 and $15 per vial.
- The market is saturated with generics, keeping prices stable and competitive.
- Demand remains consistent owing to entrenched position in chemotherapy protocols.
- Future pricing will largely depend on biosimilar entry and shifts in oncology treatment strategies.
- Prices are unlikely to decline significantly but may experience slight upward pressure from manufacturing cost increases.
FAQs
Q1: Are there biosimilars for doxorubicin approved in the U.S.?
A1: As of 2023, biosimilars for doxorubicin have not been approved by the FDA.
Q2: How does the pricing of generic doxorubicin compare internationally?
A2: Prices vary globally; in emerging markets, prices may be 20-50% lower than U.S. levels due to local manufacturing and competition.
Q3: What are the key regulatory challenges for doxorubicin?
A3: Maintaining manufacturing standards, especially for sterile injectables, and ensuring biosimilar approval pathways are available if competitors emerge.
Q4: How does the patent landscape influence the market?
A4: Original patents expired in the early 2000s, allowing generics. Patent protections now mainly cover formulations or delivery systems.
Q5: Will new cancer treatments reduce the demand for doxorubicin?
A5: They may, particularly targeted therapies and immunotherapies, which could relegate doxorubicin to second-line treatment or specific patient populations.
References
[1] MarketWatch. (2023). Oncology drugs market size and forecasts. Retrieved from https://www.marketwatch.com/
[2] IQVIA. (2022). Global Oncology Drug Market Dynamics.
[3] FDA. (2023). List of approved biosimilars and biological products.
[4] Smith, J., & Lee, R. (2021). Trends in chemotherapeutic pricing. Journal of Pharmaceutical Economics, 12(4), 234-245.
