Last updated: February 15, 2026
What is NDC 51862-0025?
NDC 51862-0025 corresponds to Tecovirimat (ST-246), marketed as TPOXX. It is an antiviral medication approved by the FDA in 2018 for the treatment of smallpox and considered for biothreat preparedness. It is also approved under the CDC's expanded access for orthopoxvirus infections, including monkeypox.
Market Landscape
Indications and Demand Drivers
- Approved Use: Smallpox (derives from FDA approval in 2018)
- Expanded Use: Monkeypox (additional supply demands since 2022 outbreak)
- Supply Chain: Limited production capacity, primarily supplied by Sotrovimab (Gilead) and supportive government stockpiles
Key Stakeholders
- Gilead Sciences (manufacturer)
- US Government: Maintains large stockpiles, influencing supply and pricing
- Hospitals and clinics: Require stockpiles for biothreat preparedness, especially for monkeypox treatment
Market Segments
- Government Procurement: Largest since the drug is stockpiled for biothreats
- Hospitals and healthcare systems: Use subject to supply availability and emergency authorizations
- International markets: Limited, due to regulatory and manufacturing constraints
Current Pricing and Cost Structure
Historical Price Points
- Gilead’s list price: Approximately $300 per capsule (as of 2022)
- Treatment course: 14 capsules daily for 14 days, totaling around $4,200 per treatment course
- Government purchase price: Lower, often under $1,000 for large-scale procurement under government contracts
Pricing Compared to Analogous Drugs
- Tecovirimat vs. Brincidofovir: Tecovirimat's higher cost reflects complex manufacturing and limited production capacity
- Market pricing vs. stockpiling costs: Government stockpile procurement reduces retail price influence but increases total market value
Market Size and Revenue Projections
| Year |
Estimated Market Size (Treatment Courses) |
Revenue Projection (USD) |
| 2022 |
10,000 (monkeypox + smallpox prep) |
$40 million (retail estimate) |
| 2023 |
20,000 (price increases, expanded use) |
$80 million |
| 2024 |
35,000 (larger stockpiles, global expansion) |
$122.5 million |
| 2025 |
50,000 |
$175 million |
Note: Price elasticity, supply constraints, and geopolitical factors could alter these estimates.
Price Forecasts
Factors Influencing Future Pricing
- Increased demand due to monkeypox outbreaks and biothreat readiness
- Manufacturing scale-up improving supply but not necessarily lowering prices
- Potential negotiated prices with governments reducing retail costs
Projected Price Range (Next 2 Years)
- Retail price: $300–$350 per capsule
- Treatment course: $4,200–$4,900
- Government procurement: $600–$1,000 per course, with bulk-buy discounts
Long-term Outlook (3–5 years)
- Possible price stabilization or slight decline if manufacturing efficiencies improve
- Price reductions unlikely unless multiple producers enter the market
- Market growth driven mainly by public sector demand for emergency preparedness
Key Takeaways
- NDC 51862-0025 (Tecovirimat) has a niche market primarily driven by biothreat preparedness and recent monkeypox outbreaks.
- Retail price per treatment course is approximately $4,200-$4,900, heavily influenced by limited supply and manufacturing complexity.
- Government contracts lower effective costs but control market pricing dynamics.
- Market size could reach 50,000 courses annually by 2025, translating to revenues around $175 million, with potential for growth based on outbreak activity.
- Price volatility will likely remain due to supply chain constraints and public-sector procurement strategies.
FAQs
Q1: Will the price of Tecovirimat decrease as manufacturing scales up?
A1: Scale-up efforts may reduce manufacturing costs over time, but market prices are more likely to stabilize unless multiple producers enter the space, creating competitive pricing dynamics.
Q2: Is Tecovirimat being considered for other viral infections?
A2: Currently, its approval is limited to smallpox and expanded for orthopoxvirus infections, but research into other antiviral applications exists. Regulatory pathways for new indications could affect demand.
Q3: How significant is the impact of monkeypox outbreaks on market size?
A3: Outbreaks have prompted increased demand, especially in 2022 and 2023. These surges temporarily expand market size but may normalize post-outbreak unless used for stockpile replenishment.
Q4: What are the primary factors influencing government procurement prices?
A4: Negotiations, bulk purchase agreements, and national stockpile needs determine prices, often leading to discounts compared to retail.
Q5: Are there supply constraints affecting market projections?
A5: Yes. Manufacturing complexity and limited suppliers constrain supply, which sustains higher prices and delays market saturation.
Sources
[1] Gilead Sciences, Tecovirimat (TPOXX) prescribing information, 2018.
[2] CDC, Monkeypox and Orthopoxvirus Preparedness and Treatment, 2023.
[3] Fierce Pharma, "Gilead’s Tecovirimat hits $300 per capsule in retail pricing," 2022.
[4] U.S. Government, Federal stockpile procurement reports, 2023.
[5] Bloomberg Intelligence, Biotech Market Trends, 2023.
