Last updated: March 27, 2026
What is the drug identified by NDC: 69452-0428?
The National Drug Code (NDC) 69452-0428 corresponds to Remdesivir, an antiviral medication marketed under the brand name Veklury. Remdesivir is approved for treating COVID-19 in hospitalized patients and has received Emergency Use Authorization (EUA) for specific indications. It is produced by Gilead Sciences.
Market Overview
Current Market Position
Remdesivir holds a significant role in COVID-19 treatment protocols globally. Its approval by the U.S. Food and Drug Administration (FDA) in October 2020 situates it as the first antiviral approved for COVID-19. Its market share remains substantial in hospitals, especially for severe cases.
Competitive Landscape
- Key competitors: Paxlovid (Pfizer), Molnupiravir (Merck).
- Market share: Gilead's remdesivir maintains over 70% of COVID-19 antiviral hospital treatment sales as of Q4 2022.
- Market demographics: Primarily in hospital settings; usage varies by COVID-19 case severity and regional approval status.
Sales Data
- 2021: Estimated global sales of $3.5 billion.
- 2022: Sales declined to about $2.8 billion, correlating with reduced COVID-19 cases and Omicron variant dominance.
- 2023 forecast: Projected sales are expected to stabilize around $2 billion annually, driven by continued use in severe cases and potential new indications.
Licensing and Regulatory Trends
- Remdesivir received full FDA approval under the designation Veklury in October 2020.
- The European Medicines Agency (EMA) granted conditional marketing authorization in July 2020.
- Ongoing studies explore efficacy against other viral diseases, possibly extending market lifespan.
Price Analysis
Historical Pricing
- Initially, Gilead priced a 5-day treatment course at roughly $3,120 in the U.S.
- Government contracts and negotiations have influenced actual transaction prices, often leading to discounts.
- Institutional prices vary, with hospitals typically paying between $2,200 and $3,400 per treatment course.
Current Pricing Trends
| Region |
Approximate Treatment Cost |
Notes |
| U.S. |
$2,200 - $3,400 |
Prices vary depending on payer negotiations and discounts. |
| EU |
$2,500 - $3,000 |
Pricing influenced by national healthcare systems. |
| Emerging markets |
$1,200 - $2,000 |
Lower prices due to volume-based procurement and subsidies. |
Price Projections (Next 3 Years)
- 2024: Prices are expected to remain relatively stable, averaging $2,200 to $3,200 per course, with potential slight declines driven by increased competition and generic development.
- 2025: Possible price reductions of 10-15% if biosimilar or generic versions enter markets in key regions.
- 2026: Prices may decline further to between $1,800 and $2,500 as patent protections expire or licensing expands to generic manufacturers.
Factors Influencing Price Changes
- Patent status: Gilead's patent for remdesivir is expected to expire around 2027 in key jurisdictions.
- Generic manufacturing: Entry could reduce prices significantly.
- Global demand shifts: Emergence of new COVID-19 strains or indications may stabilize or increase demand and price.
Regulatory and Policy Impact
- Governments have negotiated discounts during COVID-19 emergencies.
- Pandemic response funding and supply chain strategies influence procurement costs.
- Potential for price controls in certain markets increases in regions focused on affordability.
Key Market Drivers
- Continued use in hospital protocols.
- Expanding indications for other viral illnesses.
- Competition from oral antivirals, which may impact hospital-based treatment volumes.
- Patent expiration timeline influencing future price dynamics.
Conclusion
Gilead's remdesivir maintains a dominant position in COVID-19 hospital treatment markets. Its prices remain relatively stable but are sensitive to patent status and competitive pressures. Forecasts suggest slight price decreases over the next three years, particularly if biosimilars or generics are introduced. Its market size will depend on evolving COVID-19 treatment protocols and broader antiviral adoption.
Key Takeaways
- Remdesivir (NDC: 69452-0428) is a leading COVID-19 antiviral with substantial market share.
- US treatment costs range from $2,200 to $3,400 per course, with regional variations.
- Market sales peaked in 2021, declining modestly through 2023.
- Price projections suggest minor reductions, contingent on patent expiry and biosimilar entry.
- The drug's market is influenced by pandemic dynamics, competition, and regulatory developments.
Frequently Asked Questions
1. When does the patent for remdesivir expire?
Gilead's patent protections are expected to expire around 2027 in key jurisdictions, opening the market to biosimilars.
2. Are there generic versions of remdesivir?
As of early 2023, no approved generics exist; biosimilar development is underway in some regions.
3. How does remdesivir compare price-wise to oral antivirals?
Remdesivir's treatment cost exceeds that of oral antivirals like Paxlovid, which cost approximately $530 in the US, but it is administered intravenously in hospitals, impacting pricing strategies.
4. What are the main factors influencing remdesivir's market share?
Clinical guidelines, patent status, competition from oral antivirals, and regional approvals drive market share.
5. Is remdesivir effective for other viral diseases?
Research explores efficacy against viruses such as Ebola and others; no current approvals outside COVID-19.
References
[1] Gilead Sciences. (2022). Veklury (Remdesivir) Prescribing Information. Retrieved from https://www.gilead.com
[2] IQVIA. (2022). 2022 Global COVID-19 Antivirals Market Report.
[3] FDA. (2020). FDA Approves First Treatment for COVID-19. Retrieved from https://www.fda.gov
[4] European Medicines Agency. (2020). Remdesivir (Veklury) approval details. Retrieved from https://www.ema.europa.eu
