Last updated: February 15, 2026
Overview of the Drug
NDC 00093-6815 corresponds to Foscarnet Sodium, an antiviral agent primarily used to treat viral infections like cytomegalovirus (CMV) retinitis in immunocompromised patients. It is administered intravenously and holds a niche position in antiviral therapy due to its specific indications and toxicity profile.
Market Landscape
- Indication Focus: CMV retinitis, drug-resistant herpes simplex virus, and other herpesvirus infections.
- Treatment Paradigm: Foscarnet is second or third-line therapy, often reserved for cases resistant to or intolerant of nucleoside analogs such as ganciclovir.
- Market Size: Approximately 3,500–4,000 annual prescriptions in the U.S., concentrated among specialized infectious disease centers.
- Competitive Environment: Limited by availability of oral alternatives and newer antivirals like letermovir, particularly in prophylactic settings.
Key Market Drivers
- Prevalence of CMV Retinitis: Increasing in HIV/AIDS populations, especially in regions with low ART adherence.
- Drug Resistance: Rising resistance to first-line agents in immunocompromised individuals sustains demand for Foscarnet.
- Treatment Niche: Limited competition, high efficacy in resistant cases, high toxicity profile guiding cautious use.
Pricing Analysis
- Current Market Price: For the intravenous formulation, the average wholesale price (AWP) ranges between $150–$250 per 1 gram vial.
- Cost Per Treatment Regimen: Typical dosing, around 90–120 mg/kg/day for 14–21 days, results in costs approximating $2,500–$5,000 per treatment course, depending on patient weight and duration.
- Reimbursement Trends: Medicaid and Medicare reimbursement rates for hospital outpatient administers remain aligned with AWP minus discounts, influencing net healthcare provider revenue.
Historical Pricing Trends
- Recent years show a stabilization in pricing since patent exclusivity expired, with minimal price erosion.
- Production of generic versions has not significantly impacted prices, as only limited manufacturers produce this compound under FDA-approved labels.
- Notably, some hospital-based compounding generates lower costs but lacks regulatory approval for bulk distribution.
Price Projections (Next 3-5 Years)
- Market Demand Stability: Demand remains stable due to the niche treatment use; however, growth may slow with emerging therapies.
- Price Stability: Anticipate minimal fluctuation unless new formulations or licensed generics enter the market.
- Potential Price Reduction Factors: Entry of biosimilars or generics, if approved, could cut prices by 20–40%.
- Pricing Outlook: A gradual decline of approximately 5% annually is plausible, driven by healthcare system negotiations and hospital procurement strategies.
Regulatory and Policy Impact
- FDA Approvals: No recent new indications or formulations approved, contributing to price rigidity.
- Healthcare Policies: Increased emphasis on cost containment may pressure prices but limited impact on niche, high-cost injectables.
- Reimbursement Adjustments: Shifts toward value-based models could influence overall profitability.
Summary
The market for NDC 00093-6815 (Foscarnet Sodium) is characterized by steady demand in a niche segment, with current pricing maintained by limited competition. Future pricing is unlikely to sustain growth, with moderate decreases possible if alternative therapies or generics materialize.
Key Takeaways
- Foscarnet remains a critical drug for resistant viral infections despite its toxicity.
- Market demand is stable but constrained by its specialized application.
- Pricing has plateaued; potential declines depend on generics entering the market.
- No significant recent regulatory changes are expected to influence pricing.
- Cost containment efforts may further pressure prices in the upcoming years.
FAQs
1. Why does Foscarnet have limited competition?
Limited competition results from manufacturing complexities, toxicity profiles, and the small patient population. Few companies produce FDA-approved formulations, and generic version approvals are rare.
2. What factors influence the drug's high price point?
Manufacturing difficulties, regulatory exclusivity, limited competition, and the drug's specialized use underpin its high price.
3. How might new therapies affect the market?
Emerging antiviral agents with better safety profiles or oral formulations could diminish Foscarnet's market share, exerting downward pressure on prices.
4. Is Foscarnet used outside the U.S.?
Yes, it is used in select countries, often priced differently due to market dynamics, regulations, and healthcare systems.
5. Are there ongoing research initiatives affecting its future price stability?
Current research focuses on alternative therapies; no significant studies directly impacting Foscarnet’s patent or pricing are publicly reported.
Sources
[1] CDC, "Cytomegalovirus Retinitis," 2022.
[2] Medicare Drug Pricing Data, 2023.
[3] Wolters Kluwer, "Foscarnet (Foscarnet Sodium) Drug Profile," 2022.
[4] FDA Orange Book, 2023.
[5] IQVIA, "Pharmaceutical Market Analysis," 2023.
