Last updated: February 20, 2026
What is NDC 00228-2550?
NDC 00228-2550 corresponds to Doxil (doxorubicin HCl liposome injection), a chemotherapy drug used in the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. It is a liposomal formulation of doxorubicin, approved by the FDA in 1995.
Market Overview
Current Market Size
- Estimated global oncology drug market reached USD 126 billion in 2022, with targeted chemotherapies comprising approximately 40%.
- Doxil’s share within liposomal chemotherapies is considered significant, with an estimated USD 200-250 million in annual sales globally.
- Key markets include the U.S., European Union, and Japan, accounting for 85% of sales.
Competitive Landscape
| Drug Name |
Formulation |
Indications |
Market Share (2022) |
Price Range (per vial) |
| Doxil (NDC 00228-2550) |
Liposomal doxorubicin |
Ovarian cancer, Kaposi’s sarcoma, multiple myeloma |
~60% |
USD 2,100 – 3,100 |
| Lipodox |
Generic liposomal doxorubicin |
Same indications |
15% |
USD 1,300 – 2,000 |
| Myocet |
Non-pegylated liposomal doxorubicin |
Breast cancer |
10% |
USD 1,800 – 2,500 |
| Other generics |
Various |
Off-label uses |
15% |
USD 1,000 – 1,500 |
Market Drivers
- Growing demand for targeted chemotherapies with reduced toxicity.
- Expansion of indications into new cancer types.
- Increased adoption in clinical practice due to proven efficacy.
- Patent exclusivity for certain formulations ending in 2024, opening additional generic competition.
Price Dynamics
Historical Trends
- Doxil traditionally priced at USD 2,100–3,100 per 10 mg vial since 2015.
- Competition from generics has driven prices downward from a peak of USD 3,200 in 2014 to current levels.
Price Projections
| Year |
Estimated Price Range (per vial) |
Assumptions |
| 2023 |
USD 2,100 – 2,900 |
Continued generic competition, supply stability |
| 2024 |
USD 1,800 – 2,500 |
Entry of additional generic approvals, patent expirations |
| 2025 |
USD 1,600 – 2,300 |
Increased market penetration by generics |
| 2026+ |
USD 1,400 – 2,000 |
Saturation of generic market, price stabilization |
Factors Impacting Price
- Regulatory approvals for new generic versions.
- Supply chain disruptions.
- Payer negotiations and reimbursement policies.
- Patent litigations or settlement agreements.
Regulatory and Patent Status
- Original patent expired in 2015.
- Patent litigation and exclusivity periods are critical; exclusivity ending in 2024 could facilitate increased generic entry.
- FDA approvals for generics have increased from 2016 onward, speeding market entry.
Investment and R&D Implications
- Innovation in liposomal or targeted delivery platforms could extend product lifecycle.
- Biosimilar development may further influence pricing.
- Strategic partnerships with biotech firms could catalyze new indications.
Key Takeaways
- Doxil (NDC 00228-2550) operates in a competitive and mature market.
- Market share is dominated by the original product but faces increasing generic competition.
- Prices have declined since patent expiry, with forecasts indicating further reductions.
- Patent expirations in 2024 will likely accelerate generic adoption, placing downward pressure on prices.
- New formulations or indications will be necessary to sustain premium pricing.
FAQs
Q1: When will the patent for Doxil expire?
A1: Patent protections expired in 2015, but exclusivity periods for certain formulations may extend until around 2024.
Q2: How much could generics impact the market in the next five years?
A2: Generics could capture up to 80% of the market share post-2024, significantly reducing prices.
Q3: Are there biosimilar versions approved for Doxil?
A3: No biosimilars for liposomal formulations have been approved to date, but biosimilar development is ongoing.
Q4: What are the main indications for this drug?
A4: Ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma.
Q5: How are regulatory changes affecting pricing?
A5: Regulatory pathways for generics are streamlined, facilitating rapid market entry and price pressure.
References
[1] MarketWatch. (2022). Oncology drugs market size.
[2] FDA. (2022). Approved drug product label: Doxil.
[3] IQVIA. (2022). Global oncology drug sales report.
[4] U.S. Patent and Trademark Office. (2022). Patent expirations and data.
[5] Evaluate Pharma. (2022). Liposomal doxorubicin market analysis.
