Last updated: March 8, 2026
What is NDC 00185-0325?
NDC 00185-0325 refers to a specific drug product listed by the FDA National Drug Code (NDC). Based on available database information, this code corresponds to Fosaprepitant Dimeglumine Injection. It is an antiemetic used primarily to prevent nausea and vomiting associated with chemotherapy.
Market Overview
Therapeutic Class and Usage
Fosaprepitant Dimeglumine is an intravenous prodrug of aprepitant, a neurokinin-1 (NK1) receptor antagonist. It is approved for use in cancer patients receiving chemotherapy.
- Indication: Chemotherapy-induced nausea and vomiting (CINV)
- Route: Intravenous administration
- Patent Status: Approaching patent exclusivities; generic versions have entered markets.
Market Size and Trends
The global antiemetics market was valued at approximately $1.5 billion in 2022, with expectations of growing at a compound annual growth rate (CAGR) of 7% through 2027 [1].
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Key drivers:
- Rising cancer incidence globally
- Increasing adoption of IV antiemetics in clinical protocols
- Price sensitivity favoring generic options
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Leading competitors:
- Brand: Emend (Aprepitant, marketed by Merck)
- Generics: Fosaprepitant products introduced post-expiration of patents
Market Penetration of NDC 00185-0325
Fosaprepitant Dimeglumine's market share in chemotherapy-induced nausea management expanded with the entry of generics post-patent expiry, which occurred in 2017 for the original patent [2].
- Market share breakdown (2022):
- Brand (Emend IV): 45%
- Generics: 55%
Regional Insights
- United States: Largest market; significant inpatient and outpatient usage
- Europe: Growing adoption; regulations favor generics
- Asia-Pacific: Rapid expansion due to increasing cancer treatments
Regulatory and Patent Landscape
Patent Timeline
- Original patent expired in 2017, opening the market for generics [3]
- No recent patent litigation filings reported for this NDC
Approvals and Reimbursements
- Approved by FDA in 2012
- Covered broadly under Medicare and private insurance plans
Price Projections
Current Pricing Dynamics
- Brand (Emend IV): Approximate wholesale acquisition cost (WAC) over $200 per dose
- Generics (NDC 00185-0325): Ranges from $60 to $125 per dose, depending on supplier and volume
Forecasted Pricing Trends (2023-2027)
| Year |
Brand Price per Dose |
Generic Price per Dose |
Market Share (Generic) |
| 2023 |
$210 |
$70 |
55% |
| 2024 |
$205 |
$65 |
60% |
| 2025 |
$200 |
$60 |
65% |
| 2026 |
$195 |
$55 |
70% |
| 2027 |
$190 |
$50 |
75% |
Prices are estimates based on historical trends, inflation, and generic market entry pressures.
Factors Affecting Future Prices
- Increased generic competition will drive prices downward.
- Market consolidation and negotiated rebates may reduce net prices further.
- Potential regulatory changes could influence reimbursement policies.
Market Entry and Investment Opportunities
- Generics dominate the current market share, indicating high price sensitivity.
- Manufacturing: Opportunities exist in producing stable, quality-assured generics to capture increasing demand.
- Distribution: Contracting with hospital systems and large pharmacy benefit managers (PBMs) can improve margins.
Key Takeaways
- NDC 00185-0325 corresponds to a generic version of Fosaprepitant Dimeglumine injection.
- The drug operates in a $1.5 billion global antiemetics market with a CAGR of 7%.
- Post-patent expiry in 2017, generic penetration increased rapidly, now dominating over 55% of sales.
- Wholesale prices for generics are expected to decline to around $50 per dose by 2027.
- Market growth driven by increasing cancer incidence and adoption of IV antiemetics.
FAQs
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What is the expected timeline for further patent protections for this drug?
Patent protections for the original formulation expired in 2017; subsequent patent protections are limited or have expired, facilitating generic entry.
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Are there biosimilar or alternative drugs competing with NDC 00185-0325?
No biosimilars directly compete; the primary competition is from other NK1 receptor antagonists like aprepitant oral formulations and alternative antiemetics.
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How does the cost of generic Fosaprepitant Dimeglumine compare to brand versions?
Generic doses cost approximately one-third to one-half of brand prices, significantly reducing treatment costs.
-
What is the primary regulatory barrier to entry for new manufacturers?
The main barrier is ensuring bioequivalence and obtaining FDA approval; no significant patent restrictions are present currently.
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What is the outlook for new formulations or delivery methods?
Upgrades such as sustained-release formulations or combination therapies could enter the market if supported by clinical data and regulatory approval.
References
[1] Grand View Research. (2023). Anti-Emetics Market Size, Share & Trends Analysis.
[2] FDA Patent and Exclusivity Data. (2017). Fosaprepitant patent expiry.
[3] FDA Orange Book. (2022). Patent and exclusivity listings for NK1 receptor antagonists.
