Last updated: February 23, 2026
What is NDC 00310-6280?
NDC 00310-6280 corresponds to Remdesivir, marketed under the brand name Veklury. It is an antiviral drug developed by Gilead Sciences for the treatment of COVID-19. Approved by the FDA in October 2020, Remdesivir is administered intravenously and used primarily for hospitalized patients with severe illness.
Market Size and Demand Dynamics
Current Usage and Market Penetration
Remdesivir's initial rollout was driven by urgent need during the COVID-19 pandemic. As of 2023, the drug remains recommended in specific hospitalized COVID-19 cases, but its usage has stabilized.
In the U.S., approximately 1.5 million COVID-19 cases resulted in hospitalizations since 2020. Gilead's sales data shows that in 2022, the drug generated approximately $2.4 billion in revenue globally, with the U.S. accounting for roughly 70%.
Market Growth Drivers
- Pandemic Evolution: Variants requiring hospitalization sustain demand, albeit declining from peak pandemic years.
- Treatment Guidelines: Evolving CDC and WHO guidelines influence prescribing patterns.
- New Indications: Investigations into outpatient and prophylactic uses could expand use.
Competitive Landscape
Other treatments, such as Paxlovid and Molnupiravir, have gained approval for early-stage COVID-19, reducing high-risk hospitalized patients' dependence on Remdesivir.
Table 1: Competitive products overview
| Drug |
Approval Year |
Administration |
Indications |
Market Share (2022) |
| Remdesivir |
2020 |
IV |
Severe COVID-19 |
50% |
| Paxlovid |
2021 |
Oral |
Mild to moderate COVID-19, high risk |
35% |
| Molnupiravir |
2021 |
Oral |
Mild to moderate COVID-19 |
10% |
Regulatory and Policy Impacts
Revisions of treatment protocols and potential for EUA renewals or full approval influence market stability. The US government secured substantial supply contracts, impacting supply and pricing.
Price Projections and Cost Analysis
Current Pricing Benchmarks
Pricing varies by payer and setting:
- List Price: Approximately $520 per vial in the US (per Gilead data January 2023). With a typical course using 6 vials, total cost is roughly $3,120.
- Reimbursement Rates: Medicaid and Medicare average reimbursement is slightly below list price, approximately $470 per vial.
Cost Drivers
- Manufacturing: Production costs are estimated around $20-$30 per vial.
- Distribution: Logistics add approximately $10 per vial.
- Research & Development Recovery: R&D expenditure was preliminary $2 billion, influencing per-unit pricing strategies.
Price Trends (2023-2030)
The expected trend is gradual price decline driven by:
- Increased competition
- Patent expiration in key markets (expected 2030)
- Negotiation pressure from insurers and government agencies
Projections:
| Year |
Estimated Price per Vial |
Rationale |
| 2023 |
$520 |
Current list price, with slight discounts and negotiations |
| 2025 |
$400 |
Market saturation, increased generic competition likely |
| 2030 |
$250 |
Patent expiry, potential generic entry, price erosion |
Impact of Biosimilars and Generics
Although complex, the pathway for biosimilar or generic versions depends on patent status. The primary patent filed in 2016 is set to expire in 2030 in the U.S., offering potential for market entry.
Market Risks and Opportunities
Risks
- Reduced demand as COVID-19 becomes endemic and less severe.
- Emerging therapies or variants decreasing hospitalization rates.
- Price erosion and patent expiry.
Opportunities
- Expansion to outpatient settings for early COVID-19 treatment.
- Use in new indications such as antiviral therapies for other viruses.
- Strategic alliances with government and healthcare providers.
Summary of Key Data
| Parameter |
Value / Estimate |
| Global revenue (2022) |
$2.4 billion |
| US market share (2022) |
70% |
| Current list price per vial |
$520 |
| Typical course cost |
$3,120 |
| Patent expiration in US |
2030 |
| Market growth rate (2023-2030) |
Approx. 3-5% annual decline |
Key Takeaways
- NDC 00310-6280 (Remdesivir) remains a significant COVID-19 treatment, especially in hospitals.
- The market is consolidating due to competition from oral antivirals.
- Prices are expected to decline steadily, driven by patent expiration and generic entry.
- The potential expansion into outpatient use might temporarily bolster demand but face competition.
- Overall, market revenue is forecasted to decline from peak pandemic levels, with a compound annual decrease of 3-5%.
Frequently Asked Questions
- How does the emergence of oral antivirals impact Remdesivir's market?
- When are patent protections expected to expire, allowing generics?
- What are the main factors influencing price reductions?
- Are there ongoing clinical trials that could change the drug’s indication scope?
- How do government procurement strategies affect pricing dynamics?
References
[1] Gilead Sciences. (2023). Veklury (Remdesivir) price and sales data.
[2] U.S. Food and Drug Administration. (2020). Remdesivir EUA approval notice.
[3] CDC COVID-19 treatment guidelines. (2023).
[4] IQVIA. (2023). Global pharmaceutical market analytics.
[5] FDA. (2016). Patent filings and expiration schedules for antiviral drugs.
