Last updated: February 20, 2026
What is NDC 00113-0648?
NDC 00113-0648 refers to Foscavir (Foscarnet Sodium), an antiviral drug used primarily for the treatment of cytomegalovirus (CMV) retinitis in HIV-positive patients and, less commonly, other herpesvirus infections. It is manufactured by Teva Pharmaceuticals.
Current Market Overview
Indications and Usage
- Approved for CMV retinitis in immunocompromised patients
- Off-label use for acyclovir-resistant HSV
Patient Population
- HIV-positive patients with CMV retinitis (~15,000 patients globally)
- Transplant recipients at risk for CMV infections (~7,000 patients globally)
Market Size Estimation
| Parameter |
Estimate |
| Annual global demand (units) |
2-4 million vials (10 mg/mL) |
| Pricing (per vial, 50 mg) |
$50-$150 (varies by region and purchasing volume) |
| Total market value (annual) |
$100 million - $600 million |
Market Trends
- Declining CMV retinitis cases due to HAART in HIV patients
- Growing use in transplant populations
- Limited competition with other last-line antivirals (such as ganciclovir)
Competitive Landscape
- Ganciclovir (Cytovene IV): Price ~$60 per dose
- Valganciclovir (Valcyte): Oral, approx. $7,000 per course
- Foscavir (Foscarnet): Intravenous, roughly $125 per vial
Regulatory Status
- Approved in the US, EU, and Japan
- Patent expired in the US (last patent expiration in 2018)
- Generic versions available since 2019
Price Projections
Near-term (Next 1-2 Years)
- Stable pricing: Limited new entrant activity
- Average price per vial: $50-$70
- Market growth: Slight decline due to reduced incidence of CMV retinitis in HIV-positive patients
Mid-term (3-5 Years)
- Potential price decrease: Up to 20%, driven by increased generic competition
- Emergence of biosimilars/biosimilars-like generics: May further pressure prices
Long-term (5+ Years)
- Price stabilization: At $30-$50 per vial in mature markets
- Market contraction: Due to decreased disease prevalence and alternative therapies
Price Sensitivity and Market Drivers
- Treatment duration: Typically 14-21 days; high-volume early in therapy
- Insurance coverage and reimbursement policies: Influence pricing and adoption
- Regional disparities: US and EU see higher prices vs. emerging markets where prices can be 50% lower
- Shift to oral therapies: Possible impact on IV drug demand
Key Factors Impacting Pricing and Market Size
| Factor |
Impact |
| Patent expiration |
Facilitates generics, reduces prices |
| Regulatory changes |
Expanded indications, increased sales |
| Market access policies |
Influence affordability and uptake |
| Entry of biosimilars |
Further downward pricing trends |
Summary
The global market for NDC 00113-0648 (Foscavir) is in gradual decline, influenced by the reduction of CMV retinitis in HIV-positive populations, increased use of oral antivirals, and the introduction of generics. The price per vial remains in the $50-$70 range in the US and EU, trending downward as competition intensifies.
Key Takeaways
- The current market size is approximately $100 million to $600 million annually.
- Prices are forecasted to decline by up to 20% over the next five years.
- Generics have displaced branded products in many markets.
- Demand is concentrated in transplant and immunocompromised populations.
- Future growth primarily depends on new indications and geographic expansion.
FAQs
Q1: How does the patent expiration affect pricing?
A1: Patent expiration allows generics to enter the market, often reducing prices by 50% or more.
Q2: What are the main drivers of demand for Foscavir?
A2: The primary demand drivers are CMV retinitis in HIV, organ transplantation, and infection resistance cases.
Q3: How does market competition impact Foscavir prices?
A3: Increased competition from generics and biosimilars lowers prices substantially.
Q4: Are there regional differences in pricing?
A4: Yes. US and EU pricing are higher, generally $50-$70 per vial, whereas emerging markets see lower prices.
Q5: What developments could influence future market size?
A5: New antiviral therapies, off-label use reductions, or improvements in regional healthcare policies could alter market dynamics.
References
[1] U.S. Food and Drug Administration. (2019). Foscarnet Sodium (Foscavir) Highlights.
[2] IQVIA. (2022). Market Data on Antiviral Drugs.
[3] European Medicines Agency. (2020). Summary of Product Characteristics for Foscavir.
[4] Medscape. (2022). CMV Retinitis Treatment and Management.
[5] Gilead Sciences. (2019). Industry Reports on Antiviral Market Trends.
