Last updated: February 14, 2026
What is NDC 00597-0168?
NDC 00597-0168 identifies Veklury (remdesivir), an antiviral medication authorized for the treatment of COVID-19. It is marketed by Gilead Sciences and received emergency use authorization (EUA) from the FDA in May 2020.
Market Overview
Market Size & Demand:
- The global COVID-19 antiviral market experienced significant growth starting in 2020.
- As of 2022, remdesivir was among the first-approved therapies for COVID-19.
- In the U.S., the majority of demand comes from hospitals, driven by federal procurement and insurance reimbursement.
Key Market Drivers:
- U.S. government procurement agreements.
- Emergency use authorizations and subsequent FDA approval.
- Rising COVID-19 cases, including variants.
- Competition from monoclonal antibodies and oral antivirals (e.g., Paxlovid by Pfizer).
Market Challenges:
- Competition from new oral agents with easier administration.
- Pricing scrutiny and reimbursement restrictions.
- Varied international regulatory environments.
Market Penetration:
- Gilead's initial supply agreements with the U.S. government set high market penetration in 2020-2021.
- Decline in usage as treatment guidelines shifted and oral therapies emerged reduces volume.
Global Reach:
- Remdesivir received approval or emergency use authorization in multiple countries.
- Financing and import restrictions limit access in low-income regions.
Pricing Trends & Projections
Current Price Points:
- Gilead's publicly documented price for a 5-day course (6 vials) is approximately $2,340 per treatment in the U.S. (per Gilead's published prices as of 2021).
- Reimbursement rates vary by payers: Medicare, private insurers, hospitals.
Historical Pricing:
| Year |
Price per Course |
Notes |
| 2020 |
~$2,340 |
Initial pricing aligned with EUA guidelines |
| 2021 |
~$2,340 |
Maintained with minor adjustments for inflation |
| 2022-2023 |
Slight variations |
Some payers negotiated discounts or reduced rates |
Factors Affecting Future Prices:
- Patent and exclusivity status: Gilead's patent protection for remdesivir extends through 2032.
- Market competition: The introduction of oral antivirals like Paxlovid has reduced hospital demand.
- Patent challenges or biosimilar development: Currently limited for remdesivir.
- Regulatory decisions: FDA approval beyond EUA may expand or limit indications, affecting volume and pricing strategies.
- Reimbursement policies: Insurance coverage and government programs influence effective pricing.
Price Projection (2024-2028):
- Stability in list prices: Likely to remain near current levels given patent protection and limited immediate biosimilar competition.
- Potential discounts: Expected as hospitals negotiate bulk purchasing agreements.
- Impact of Generics/Manufacturing: If biosimilars or generics emerge post-2032, prices could decline rapidly.
Market Outlook & Competitive Landscape
| Competitor |
Product |
Status |
Estimated Market Share |
Key Differentiator |
| Gilead Sciences (Veklury) |
Remdesivir |
Market leader (initial phase) |
60–70% |
First authorized, extensive procurement agreements |
| Pfizer |
Paxlovid |
Oral antiviral, FDA approved |
20–25% |
Ease of use, high efficacy in early treatment |
| Merck & Ridgeback |
Lagevrio (Molnupiravir) |
FDA approved |
5–10% |
Oral tablet, alternative to intravenous IV therapy |
Market Share Dynamics:
- As oral options become standard in outpatient settings, hospital-administered remdesivir's share declines.
- The reduction in COVID-19 hospitalizations decreases overall demand for IV antivirals.
Future Market & Price Drivers
- Therapeutic Guidelines: COVID-19 treatment protocols increasingly favor oral agents locking remdesivir’s hospital role.
- Reimbursement Trends: Shift toward value-based pricing and negotiated discounts.
- Global Expansion: Emerging markets may face affordability and regulatory barriers, limiting growth.
- Manufacturing Capacity: Gilead's production capabilities help maintain supply stability but are unlikely to significantly impact pricing without biosimilar competition.
Summary
- Gilead’s remdesivir (NDC 00597-0168) has maintained list prices around $2,340 per treatment course since 2020.
- Market demand peaked early, with volume affected by emerging oral therapies and evolving treatment guidelines.
- Future pricing will primarily hinge on volume demand, reimbursement negotiations, and regulatory decisions, with prices expected to stabilize unless biosimilar competition arises after patent expiry around 2032.
Key Takeaways
- The initial U.S. market for remdesivir was driven by federal procurement, with list prices around $2,340 per course.
- Its role in COVID-19 treatment is likely to diminish with increased adoption of oral antivirals.
- Pricing is expected to stabilize in the short term with minor discounts in negotiated agreements.
- Entry of biosimilars post-2032 could substantially lower prices.
- Global access remains limited by affordability and regulatory hurdles in emerging markets.
FAQs
1. Will remdesivir’s price decrease before patent expiration?
Limited, unless Gilead reduces list prices to maintain market share or due to competitive pressures from biosimilars.
2. How does remdesivir compare to oral antivirals in pricing?
Oral antivirals, such as Paxlovid, are priced significantly lower, around $700-$1,000 per treatment course, and offer easier outpatient administration.
3. What impact do emerging COVID-19 treatments have on remdesivir’s market?
They decrease demand for hospital-based IV antivirals, reducing overall market size and sales volume.
4. Are there regional variations in remdesivir pricing?
Yes; reimbursement rates and procurement strategies vary globally, often resulting in lower prices outside the U.S.
5. When might biosimilar versions of remdesivir become available?
Post-2032, upon patent expiry, assuming no patent challenges or regulatory delays, biosimilars could enter the market and drive prices down.
References
- Gilead Sciences. (2021). Veklury (remdesivir) pricing and product information.
- FDA. (2020). Emergency Use Authorization for Veklury.
- IMS Health. (2022). Antiviral Market Data.
- Reuters. (2022). Gilead's remdesivir global sales analysis.
- Statista. (2023). COVID-19 antiviral drug market projections.
