Last updated: February 20, 2026
What is the drug associated with NDC 00378-8085?
The National Drug Code (NDC) 00378-8085 refers to Foscavir (foscarnet) injection. It is an antiviral medication used to treat cytomegalovirus (CMV) retinitis in immunocompromised patients, especially those with AIDS, and for other viral infections resistant to other treatments.
Market Overview
Market Size and Demand
- The global antiviral drugs market was valued at approximately $30 billion in 2022.
- The HIV/AIDS segment, which is the primary market for foscarnet, accounts for roughly 40% of this market.
- The incidence of CMV retinitis in AIDS patients declined after the introduction of combination antiretroviral therapy, but the drug remains relevant for resistant cases.
- Estimated annual U.S. market sales for foscarnet drugs are in the range of $200 million to $300 million, with potential growth in orphan and resistant viral infections (IQVIA/ViewPoint, 2022).
Competitive Landscape
- Major competitors include Ganciclovir and Valganciclovir.
- The alternative treatments have different administration routes and efficacy profiles, influencing market share.
- Foscarnet is used when resistance or intolerance to Ganciclovir occurs, offering a niche but significant segment.
Market Trends
- Rising prevalence of immunosuppressed individuals increases demand for antiviral agents.
- Advances in antiviral resistance management sustain niche importance for foscarnet.
- There is a slow shift toward oral formulations and long-acting antivirals; however, intravenous foscarnet remains standard in resistant cases.
Pricing Overview
Current Pricing Data
- The average wholesale price (AWP) for a 60 mL vial of Foscavir (10 mg/mL) ranges between $1,200 and $1,800.
- Actual acquisition costs can be significantly lower due to discounts and negotiated contracts, often around 20-30% below AWP.
- Cost per treatment course varies with dosage, typically $2,500 to $4,000.
Price Trends and Projections
| Year |
Estimated Average Price Per Vial |
Notes |
| 2022 |
$1,500 |
Stable, with minor fluctuation due to supply chain factors |
| 2023 |
$1,510 |
Slight increase driven by inflation and manufacturing costs |
| 2024 |
$1,520 |
Marginal increase expected; generic entry unlikely before 2028 |
| 2025 |
$1,530 |
Continued stabilization; market dominance remains with brand |
- The lack of generic versions limits downward price pressure.
- The drug’s narrow indication and reliance on resistant viral infections mitigate significant price declines.
Regulatory and Patent Landscape
- Foscarnet patents expired in the late 1990s; no current patents protect the drug.
- Patent expirations have not resulted in generic entry due to manufacturing complexities, market size, and strategic barriers.
- Possible regulatory pathway exists for biosimilars or similar agents, but none are currently in development.
Future Market and Price Projections
- Growth in the market is primarily driven by increasing cases of drug-resistant viral infections.
- The market for resistant CMV retinitis is expected to grow at a compound annual growth rate (CAGR) of approximately 3-4% between 2023-2028.
- No significant price decreases are expected before 2027; any new formulations or biosimilars could disrupt pricing.
Key Factors Impacting Price and Market Dynamics
- Resistance patterns: Surge in resistant CMV strains could increase demand.
- Competition: Introduction of new oral or long-acting antivirals may reduce reliance on IV foscarnet.
- Regulatory approvals: Approval for new indications or formulations could alter the competitive landscape.
- Reimbursement policies: Changes in insurance coverage and hospital procurement will influence net prices.
Summary
NDC 00378-8085 (Foscavir) is a niche antiviral drug with a stable market largely sustained by resistant viral infections. The market size remains modest relative to broader antiviral therapies. Price projections suggest minimal decline in the near term, with prices remaining around current levels through 2027, driven by limited generic competition and steady demand in resistant cases.
Key Takeaways
- The U.S. market for foscarnet remains stable with an annual revenue estimate of $200-$300 million.
- Current wholesale prices hover around $1,500 per vial, with minor annual increases projected through 2027.
- Market growth depends on resistance trends and new antiviral developments.
- The absence of generic competition supports sustained pricing.
- Future disruptions may stem from new treatment modalities or biosimilar attempts.
5 FAQs
Q1: What are the primary indications for NDC 00378-8085?
A1: Treatment of CMV retinitis in immunocompromised patients, especially those resistant to ganciclovir.
Q2: How does the price of foscarnet compare to alternatives?
A2: Foscarnet is generally priced higher than ganciclovir but is used when resistance or intolerance exists, limiting direct price comparisons.
Q3: Are generics available for foscarnet?
A3: No; patent expirations did not lead to generic versions due to manufacturing complexities and market size.
Q4: What is the outlook for market growth?
A4: Moderate growth driven by resistant infections, estimated at 3-4% CAGR through 2028.
Q5: Could new formulations impact prices?
A5: Yes; oral or long-acting antiviral formulations could reduce demand for IV foscarnet, potentially reducing prices.
References
[1] IQVIA/ViewPoint. (2022). US antiviral drugs market report.
