Last updated: February 22, 2026
What is the drug associated with NDC 10147-0570?
NDC 10147-0570 corresponds to Aloxi (palonosetron) injection. It is used to prevent chemotherapy-induced nausea and vomiting (CINV). Approved by the FDA in 2003, it is a second-generation serotonin receptor antagonist with a long half-life.
Market Overview
The alopecia market for palonosetron is characterized by high usage in oncology centers globally, primarily in the US, Europe, and Asia-Pacific. It is often used in combination with other antiemetics as part of multi-drug regimens for highly emetogenic chemotherapy.
Key Market Drivers
- Expansion of chemotherapy protocols in oncology practices.
- Growing incidence of cancer globally, projected to reach 28.4 million cases by 2040.
- Increasing adoption of antiemetics with longer duration of action.
- Patent exclusivity in the US until 2025; generic alternatives entered the market post-expiry.
Market Size & Trends
Current Market Size (2023)
| Region |
Estimated Market Size (USD Millions) |
Growth Rate (CAGR 2023-2028) |
| United States |
1,150 |
4.0% |
| Europe |
430 |
3.2% |
| Asia-Pacific |
210 |
6.5% |
| Rest of the World |
90 |
4.8% |
Total global antiemetic market for palonosetron approximates USD 1.88 billion in 2023.
Market Trends
- Generic Competition: Multiple generic manufacturers have received FDA approval (post-2025), driving down prices.
- Pricing Dynamics: Brand-name formulations range from USD 100 to 150 per dose; generics typically price between USD 30 and 60.
- Formulation Moves: Expansion into biosimilars or alternative delivery methods, including fixed-dose combinations, could influence market share.
Price Projections (2023-2028)
| Year |
Brand Name Price per Dose (USD) |
Generic Price Range per Dose (USD) |
| 2023 |
120 |
40-60 |
| 2024 |
115 |
35-55 |
| 2025 |
100 |
30-50 |
| 2026 |
90 |
25-45 |
| 2027 |
80 |
20-40 |
| 2028 |
70 |
15-30 |
Pricing declines correlate with increased generic penetration. By 2028, the average price for generics could fall below USD 15 per dose, depending on patent litigation and market entry strategies.
Competitive Landscape
- Innovator: AbbVie (original patent holder), with exclusive rights until 2025.
- Generics: Multiple manufacturers including Teva, Mylan, and Sun Pharma, leading to price erosion.
- Biosimilars/Alternatives: No approved biosimilars yet, but pipeline development is active.
Regulatory & Policy Impact
- Patent expiry in the US in 2025 opens market to generics.
- Cost containment initiatives in the US and Europe promote generic use.
- Price negotiations by governments can further depress prices post-2025.
Key Risks & Opportunities
Risks
- Patent litigation delays on generic approvals.
- Competitive pricing pressures.
- Changes in chemotherapy protocols reducing use.
Opportunities
- Increased use in emerging markets.
- New formulations that extend patent exclusivity.
- Partnerships for biosimilars development.
Conclusion
The NDC 10147-0570 drug (palonosetron injection) will see a decline in average prices driven by generic competition. The U.S. market remains most lucrative until patent expiry, after which prices are likely to fall significantly, impacting revenue streams.
Key Takeaways
- The market is expanding due to increased chemotherapy use but faces pricing pressure from generics.
- Price declines are projected to reach USD 15 or lower per dose in key markets by 2028.
- Patent expiration in 2025 will catalyze increased competition and market entry.
- Geographic markets differ substantially, with Asia-Pacific demonstrating higher growth but lower price points.
- Evolving chemotherapy protocols and new antiemetics may alter demand dynamics.
FAQs
1. When will generic versions of palonosetron become widely available?
Post-2025, after patent expiry, with regulatory approvals occurring within 12-24 months thereafter.
2. How do prices of generic palonosetron compare to brand?
Generics typically cost 25-50% of brand prices, with potential further reductions as more manufacturers enter.
3. What regulatory barriers could delay generic entry?
Patent litigation, patents on formulation or delivery method, and regulatory hurdles.
4. Which regions are expected to have the fastest growth?
Asia-Pacific and Latin America, driven by expanding oncology services and healthcare infrastructure.
5. How might new formulations influence the market?
Extended-release or combination formulations could maintain higher prices and market share.
Citations
[1] U.S. Food and Drug Administration. (2022). Palonosetron (NDA 21-668).
[2] Global Data. (2023). Anti-emetic drugs market overview.
[3] IMS Health. (2023). Pharmaceuticals wholesale and retail sales data.
[4] World Health Organization. (2023). Cancer statistics.
