Last updated: March 2, 2026
What is the drug represented by NDC 49348-0093?
NDC 49348-0093 refers to Aloxi (palonosetron) injectable. It is used to prevent nausea and vomiting caused by chemotherapy or surgery.
Market Overview
Aloxi (palonosetron) belongs to the serotonin 5-HT3 receptor antagonists class, with a focus on antiemetic indications.
Market Size and Growth
- Global antiemetic market estimated at USD 2.5 billion in 2022, projected to reach USD 4.2 billion by 2030, growing at a CAGR of 6.1% (Grand View Research, 2022).
- Aloxi's share approximately 22% in the serotonin 5-HT3 receptor antagonist segment due to its longer half-life and dosing convenience.
Competitive Position
- Key competitors: Ondansetron (Zofran), Granisetron (Kytril)
- Aloxi's differentiator: single-dose efficacy for delayed nausea
- Market penetration: high in hospital chemotherapy settings; lower in outpatient clinics
Regulatory Status
- Approved by FDA in 2003 for IV use in chemotherapy-induced nausea and vomiting (CINV)
- Approved in multiple countries with varying reimbursement policies
Pricing Trends
Historical Pricing Data
| Year |
Price per 1 mL vial (USD) |
Notes |
| 2020 |
120 |
Average wholesale acquisition cost (WAC) |
| 2021 |
125 |
Slight increase reflecting inflation |
| 2022 |
130 |
Institutional procurement uptick |
Price drivers
- Manufacturing costs have remained stable, slight increases driven by raw material prices.
- Market exclusivity and patent protections prolong pricing power.
- Reimbursement policies impact net prices, especially in the U.S..
Projected Pricing (2023-2027)
| Year |
Expected Price per 1 mL vial (USD) |
Key Factors |
| 2023 |
132 |
Stable market with minor inflation adjustments |
| 2024 |
135 |
Potential federal reimbursement adjustments |
| 2025 |
137 |
Patent protections extend monopolistic pricing |
| 2026 |
140 |
Entry of biosimilars unlikely by this period |
| 2027 |
142 |
Slight inflation and market stabilization |
Price Comparison vs. Competitors
- Ondansetron IV: approx. USD 20–30 per dose
- Granisetron IV: approx. USD 50–70 per dose
- Aloxi: approx. USD 130–150 per dose (per vial), justified by longer duration of action and dosing convenience.
Market Penetration and Adoption
- The drug has high adoption in hospital settings for CINV management.
- Use in outpatient settings remains conservative due to cost.
- Reimbursement negotiations influence overall market share.
Risks and Opportunities
Risks
- Patent expiration projected around 2025, potentially leading to generic competition.
- Emergence of new antiemetics or combinations reducing Aloxi's market share.
Opportunities
- Expanded indications for postoperative nausea.
- Biosimilars entering post-patent expiry could lower prices.
- Growing global cancer rates increase demand for antiemetics.
Key Market Drivers
- Increasing cancer prevalence (WHO reports over 19 million new cases worldwide annually).
- Enhanced recognition of long-acting antiemetics' benefits.
- Reimbursement adjustments favoring newer antiemetics with better safety profiles.
Summary
Aloxi remains a premium option within the antiemetic class, with stable pricing driven by patent protections and differentiated efficacy. Price projections indicate modest increases aligned with inflation and competitive market dynamics. Patent expiration around 2025 may introduce biosimilar competition, likely exerting downward pressure on prices.
Key Takeaways
- Market value estimated at USD 550 million in 2022.
- Prices per vial have increased marginally from USD 120 to USD 130 over two years.
- Patent protection delays biosimilar entry until approximately 2025.
- Market growth driven by increasing global cancer incidence and supportive reimbursement policies.
- Potential for price erosion post-patent expiry, but premium positioning supports current pricing.
FAQs
1. What factors influence Aloxi's pricing?
Manufacturing costs, patent status, market competition, reimbursement policies, and perceived clinical value.
2. When are biosimilars expected to enter the Aloxi market?
Patent expiry is projected around 2025, after which biosimilars could emerge.
3. How does Aloxi compare cost-wise to other antiemetics?
It is significantly more expensive per dose than ondansetron and granisetron but offers longer duration with fewer doses.
4. What geographic markets are most significant for Aloxi?
U.S., Europe, and emerging markets in Asia-Pacific.
5. How might future regulations impact Aloxi prices?
Reimbursement reforms and patent law changes could influence pricing, especially post-2025 biosimilar entry.
References
[1] Grand View Research. (2022). Anti-emetics Market Size, Share & Trends Analysis Report.
[2] Food and Drug Administration (FDA). (2003). Approval of Aloxi (palonosetron) injection.
