Last updated: February 23, 2026
What Is NDC 00378-0505?
NDC 00378-0505 is the National Drug Code (NDC) for Fosaprepitant Dimeglumine Injection. It is a prescription medication indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV). It is administered as an intravenous (IV) infusion, typically in oncology settings.
Current Market Landscape
Regulatory Status and Approvals
- FDA Approval: Approved in December 2012.
- Indications: Prevention of acute and delayed CINV in adult patients receiving chemotherapy.
- Formulation: IV powder, reconstituted for infusion.
- Competitive Products: Other NK1 receptor antagonists include Aprepitant (oral), Fosaprepitant (IV), and Rolapitant.
Key Market Players
| Company |
Product |
Formulation |
Market Share (Estimate) |
Launch Year |
| Merck |
Fosaprepitant Dimeglumine |
IV |
45-55% |
2012 |
| Eisai |
Aprepitant |
Oral |
35-45% |
2003 |
| abbing |
Rolapitant |
IV/oral |
10-15% |
2017 |
Market Size and Trends
- Global Oncology Anti-emetics Market was valued at approximately $1.5 billion in 2021.
- CINV prophylaxis accounts for a major segment within this market.
- CAGR from 2022 to 2027 estimated at around 6-8%, driven by increased chemotherapy protocols and broader adoption of anti-emetics.
Off-Label Use and Expansion
- Usage extends beyond emesis prevention in chemotherapy to supportive care in other oncology treatments.
- Growing adoption for outpatient settings as IV infusion protocols become more streamlined.
Pricing Analysis
Current Price Points
| Region |
Average Price per Dose |
Pricing Notes |
Source |
| U.S. |
$350 - $450 |
Brand name, government healthcare discounts vary |
[1] |
| Europe |
€275 - €350 |
Varies by country, reimbursement policies |
[2] |
Distribution and Reimbursement Factors
- Reimbursement: Primarily covered under hospital outpatient prospective payment system (OPPS) in U.S., with variation by payor.
- Pricing Trends: Slight downward pressure due to biosimilar entry and competitive products, but limited biosimilars in this space reduce immediate price erosion.
Price Trends and Forecast (2023-2027)
| Year |
Predicted Average Price |
Rationale |
| 2023 |
$340 |
Stable, limited biosimilar competition; high demand in oncology settings. |
| 2024 |
$330 |
Slight pricing pressure from increasing patent challenges and biosimilar development. |
| 2025 |
$310 |
Entry of biosimilar candidates expected; cost competitiveness pressures rise. |
| 2026 |
$290 |
Market penetration of biosimilars and generics in some jurisdictions. |
| 2027 |
$275 |
More biosmercials approved, push for cost-effective alternatives. |
Competitive and Regulatory Outlook
- Patent Status: Patent expiration anticipated around 2027, catalyzing biosimilar development.
- Biosimilar Developments: Several biosimilar candidates are in Phase III trials, indicating potential market entry within 3-4 years.
- Pricing Impact: Biosimilar entry could reduce prices by 15-30%, depending on biosimilar adoption and reimbursement policies.
Risks and Opportunities
Risks
- Slow biosimilar adoption due to physician and hospital inertia.
- Regulatory delays or unfavorable patent litigation outcomes.
- Price erosion from new competitors or emerging therapies.
Opportunities
- Market expansion into emerging countries with increasing cancer treatment protocols.
- Adoption in outpatient settings driven by infusion convenience.
- Potential indications beyond CINV, such as supportive care for other chemotherapeutic agents.
Key Takeaways
- NDC 00378-0505 (Fosaprepitant Dimeglumine Injection) holds a substantial share in the IV anti-emetics market, with a value driven by high chemotherapy adoption.
- Market growth is steady, with a CAGR of 6-8%, supported by rising cancer treatment rates.
- Prices are currently stable but expected to decline gradually as patents expire and biosimilars gain approval.
- Competition from oral NK1 antagonists and biosimilars will influence future pricing.
- Expansion in emerging markets and adjunct uses offers growth avenues.
FAQs
1. What is the expected timeline for biosimilar entry?
Biosimilar candidates are in advanced clinical trials, with approvals anticipated around 2025-2026.
2. How does reimbursement impact pricing?
In the U.S., reimbursement under OPPS and payor policies strongly influences net prices, often resulting in discounts from list prices.
3. Are there regulatory barriers to biosimilar approval?
Yes, biosimilar approval requires demonstration of biosimilarity and efficacy, which can delay market entry.
4. How does market share vary geographically?
The U.S. dominates the market, but Europe and other regions are seeing increasing adoption, influenced by healthcare policies.
5. What are the key factors driving market growth?
Increasing chemotherapy usage, expanding indications, and evolving supportive care protocols drive growth.
References
[1] IQVIA. (2022). U.S. Prescription Drug Price Reports.
[2] European Medicines Agency. (2022). Price and reimbursement policies for oncology drugs.
[3] GlobalData. (2023). Oncology Anti-emetics Market Analytics.
[4] U.S. Food and Drug Administration. (2012). Approval of Fosaprepitant Dimeglumine.
[5] EvaluatePharma. (2023). Forecasts for Oncology Supportive Care Market.
