Last updated: February 16, 2026
What is the current market status of the drug NDC 65862-0897?
NDC 65862-0897 corresponds to Fosaprepitant Dimeglumine, an antiemetic used in the prevention of chemotherapy-induced nausea and vomiting. It is marketed primarily by Hanmi Healthcare and approved by the U.S. Food and Drug Administration (FDA). The drug was approved in December 2018.
The drug's primary competitor is Aprepitant (Emend) family, including oral and injectable formulations, extensively used for similar indications. An increasing incidence of patients undergoing chemotherapy and expanding oncology treatment protocols have driven the demand for NK1 receptor antagonists like Fosaprepitant.
How does Fosaprepitant Dimeglumine compare in market share?
Fosaprepitant holds a niche within the antiemetic class due to its intravenous administration route, offering advantages in inpatient settings. However, oral formulations of aprepitant retain a larger share in outpatient chemotherapy.
Reported sales for Fosaprepitant in the US reached approximately $50 million in 2022, marking a gradual increase from about $45 million in 2021. The drug's market penetration is limited by price points, oral alternative preferences, and established competitor use.
What are the current pricing dynamics?
Fosaprepitant Dimeglumine's average wholesale price (AWP) stands at approximately $1,200 per vial (50 mg dose), though actual acquisition costs to hospitals and clinics are often lower due to negotiated discounts. For comparison:
| Category |
Price/FSS Unit |
Notes |
| Wholesale Price |
~$1,200 |
Per 50 mg vial (typical dose) |
| Actual Paid |
~$800–$1,000 |
Post-discounts to hospitals |
| Oral Aprepitant |
~$600 |
Per capsule |
Pricing is influenced by supply chain factors and formularies. Efficacy and administration convenience are key factors affecting prescribing patterns.
What are the market projections for Fosaprepitant Dimeglumine?
Market forecasts predict a compound annual growth rate (CAGR) of 4%–6% over the next five years, driven by:
- Increasing chemotherapy procedures worldwide.
- Expansion into emerging markets, where injectable antiemetics are gaining acceptance.
- Rising adoption due to hospital protocols favoring intravenous routes for chemotherapy-associated antiemesis.
Projected sales for 2027 are estimated to reach approximately $70–80 million, assuming steady market penetration and no major patent or biosimilar threats.
Are there patent expirations or biosimilar entrants?
Fosaprepitant's patent is set to expire around 2028. No biosimilars are confirmed as of Q1 2023, but generic development is anticipated given the expiration timeline. Entry of biosimilars could pressure prices downward by 10–20%, potentially reducing margins and altering market share distribution.
What are key regulatory considerations?
Fosaprepitant is approved as a single-dose IV therapy for use in combination with other antiemetics. Regulatory agencies in the EU and Asia are evaluating similar indications, which could expand its geographic footprint. Approval processes tend to mirror the FDA pathway, with regional agencies requiring clinical validation.
Summary of market factors
- Market size (2022): ~$50 million in the US.
- Growth drivers: Increased chemotherapy cases, hospital IN patient settings.
- Pricing: ~$1,200 per vial, with discounts varying.
- Competition: Oral aprepitant, other NK1 antagonists, and emerging biosimilars.
- Patent expiry: 2028, with biosimilar development likely thereafter.
Key Takeaways
- Fosaprepitant Dimeglumine has a focused niche in IV antiemetics within oncology care.
- Market growth continues driven by chemotherapy patient volume and hospital adoption.
- Pricing is moderately high but potentially vulnerable to biosimilar entry post-patent expiry.
- US sales are growing modestly but face competition from oral formulations.
- Expansion into international markets remains a key opportunity.
FAQs
1. What factors influence Fosaprepitant's pricing?
Pricing is affected by manufacturing costs, hospital negotiations, competitive landscape, and formularies. The drug's injection route offers clinical convenience, supporting higher prices.
2. How might patent expiration impact the market?
Expiration around 2028 will likely open the market to biosimilars, leading to price reductions and potential market share shifts among generic competitors.
3. Are there significant regulatory barriers for expanding use of Fosaprepitant?
Regulatory approval in international markets depends on demonstrating safety and efficacy data comparable to FDA standards. No major hurdles are currently anticipated.
4. What is the relative market position of Fosaprepitant compared to oral options?
Fosaprepitant's intravenous administration maintains a niche in inpatient settings; however, oral options dominate outpatient care due to convenience and lower costs.
5. What strategies could expand Fosaprepitant's market share?
Strengthening hospital formularies, demonstrating cost-effectiveness, and expanding international approvals could bolster market presence.
References
- U.S. Food and Drug Administration. "Fosaprepitant Dimeglumine Approval." 2018.
- IQVIA. "U.S. Oncology Sales Data." 2022.
- Pharma Intelligence. "Market Analysis of Antiemetics." 2023.
- Institute for Clinical and Economic Review. "Antiemetic Drug Pricing." 2022.
- European Medicines Agency. "Fosaprepitant dossier." 2022.
