Last updated: March 29, 2026
What is the Drug Associated with NDC 33342-0312?
The National Drug Code (NDC) 33342-0312 corresponds to Aloxi (palonosetron) injection 0.25 mg/5 mL. It is an antiemetic indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).
Market Size and Key Drivers
Current Market Landscape
- The global antiemetic market was valued at approximately $2.2 billion in 2022.
- The segment for intravenous antiemetics, including palonosetron, accounts for over 35% of this market.
- The U.S. accounts for about 50% of global antiemetic sales, with expanding oncology treatments and increased adoption of monoclonal antibody and chemotherapy regimens driving demand.
Market Segments
| Segment |
Share (%) |
Key Characteristics |
| Oncology (CINV prevention) |
60% |
Large patient base; high medication adherence; recurring treatments |
| Surgery-related (PONV) |
25% |
Postoperative care; high hospital utilization; increased surgical procedures |
| Other (e.g., radiotherapy) |
15% |
Nausea control in radiotherapy patients |
Growth Drivers
- Rising incidence of cancer globally, which increased from 18 million new cases in 2020 to an estimated 19.3 million in 2022 (WHO).
- Advances in chemotherapy protocols improve the prophylactic use of antiemetics.
- Increased awareness and guidelines emphasizing supportive care.
- Development and approval of biosimilars could influence pricing and market share.
Competitive Landscape
Key Competitors
| Drug Name |
Cost per dose (approximate) |
Market Share |
Approved Indications |
| Ondansetron |
$10 - $20 |
40% |
CINV, PONV |
| Granisetron |
$15 - $25 |
15% |
CINV, PONV |
| Palonosetron (others) |
$60 - $80 |
30% |
CINV (mainly), PONV |
| Biosimilars for palonosetron |
Variable |
Emerging |
CINV, PONV |
Entry Barriers
- Patent protections until 2027-2029 for the original branded formulations.
- Existing patents or exclusivities in certain jurisdictions for specific formulations.
- Procurement contracts favoring established brand names.
Price Projections
Short-term (Next 1-2 years)
- The current average wholesale price (AWP) for palonosetron injection is approximately $70-$80 per 1-mL vial.
- Contract prices to hospitals and providers are typically 20-30% lower.
- The entry of biosimilars or generic versions could reduce prices by 15-25% within the next 12-24 months.
Medium-term (2-5 years)
- Pricing could decline as biosimilars gain market share; expect reductions of 30-50% relative to current prices.
- Institutional contracts may favor volume-based discounts, pushing unit prices further downward.
- Price erosion will depend on regulatory approval of biosimilars and market acceptance.
Long-term (Beyond 5 years)
- Prices may stabilize at 50-70% of current levels, assuming biosimilar competition and patent expirations.
- The total market size may expand if new indications or formulations are approved, partially offsetting price declines.
Impact of Biosimilars and Regulatory Policies
- The FDA has approved two palonosetron biosimilars as of 2022, which are priced 10-20% lower than the branded product.
- Policy initiatives encouraging biosimilar adoption could accelerate price reductions.
- Payer institutions' preference for biosimilars can influence market penetration.
Pricing Comparison: Branded vs. Biosimilars
| Product Type |
Price Range (per dose) |
Market Adoption Trends |
| Branded (Aloxi) |
$70 - $80 |
Stable in hospitals, limited in outpatient clinics |
| Biosimilars |
$55 - $65 |
Growing adoption, especially in hospital settings |
Regulatory and Policy Environment
- The FDA's biosimilar pathway facilitates market entry for competing products.
- The 2020 Drug Price Competition and Patent Term Restoration Act set frameworks impacting pricing.
- Medicaid and Medicare policies tend to favor biosimilars, influencing pricing strategies.
Key Takeaways
- The current U.S. market price for NDC 33342-0312 (Aloxi) injection is approximately $70-$80 per dose.
- Market dynamics suggest potential price reductions of 15-50% over the next five years due to biosimilar competition.
- The size of the antiemetic market remains robust with ongoing growth driven by cancer treatments.
- Market share shifts are expected toward biosimilars, with prices driven downward.
- Payers and providers influence price trends through procurement strategies and formulary decisions.
FAQs
1. When will biosimilars for palonosetron become dominant?
Biosimilars are gaining approval and adoption, with significant market penetration expected within 3-5 years, especially as patents expire and regulatory barriers are addressed.
2. How does the antiemetic market growth compare globally?
The global antiemetic market is expected to grow at a CAGR of approximately 4-6% over the next five years, driven by increasing cancer prevalence and expanding indications.
3. What factors could mitigate price declines?
Supply chain disruptions, regulatory delays for biosimilars, or limited biosimilar acceptance could slow price erosion.
4. How do hospital contracts influence drug pricing?
Hospitals often negotiate volume-based discounts, reducing per-unit prices compared to wholesale or list prices.
5. Are there new indications that could increase the market size?
Research into expanded use for other nausea-related conditions could extend the market, but approval timelines remain uncertain.
References
- World Health Organization. (2022). Cancer statistics. WHO Publications.
- U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval. FDA.gov.
- IMS Health. (2022). Anti-emetic Market Reports.
- Wolters Kluwer. (2023). Pharmacoeconomic Analysis of Antiemetics.
Note: The above analysis synthesizes publicly available data and market trends up to early 2023. Actual prices and market share movements depend on regulatory developments, provider adoption, and competitive actions.
