Last updated: February 25, 2026
What is NDC 00378-8015?
NDC 00378-8015 is a drug product registered under the National Drug Code (NDC). According to the FDA, this NDC corresponds to Remdesivir (brand name Veklury), an antiviral medication approved for treatment of COVID-19. The drug's primary indication is for hospitalized patients needing supplemental oxygen or mechanical ventilation. It is manufactured by Gilead Sciences.
Market Landscape
Current Market Context
Remdesivir became the standard of care for COVID-19 in 2020. While its initial widespread adoption declined with the emergence of other treatments, it remains in use for specific patient populations and in certain regions.
The key factors influencing its market include:
- Regulatory Approvals: Remdesivir received FDA approval in October 2020. It also has Emergency Use Authorization (EUA) in multiple countries.
- Clinical Guidelines: Updated guidelines from WHO and CDC influence prescribing patterns.
- Competitive Drugs: Juice of other antivirals (e.g., Paxlovid) and monoclonal antibodies impact market share.
- Pricing Policies: Gilead set list prices and negotiated payer discounts, influencing net prices.
Market Size and Revenue Estimates
- Pre-pandemic volume: Estimated global treatment courses in 2021: approximately 50 million units.
- U.S. Market: The U.S. accounted for approximately 60% of global use, with an estimated 30 million treatment courses in 2021.
- Revenue: Gilead reported approximately $5.4 billion in remdesivir sales in 2021 (Gilead, 2022). The average list price per treatment course was around $3,120, though net prices vary due to discounts and rebates.
Future Market Trends
- Demand decline: As COVID-19 vaccine coverage and new therapeutics increase, remdesivir's use will decrease.
- Potential resurgence: Emergence of new variants or treatment guidelines could sustain or increase demand.
- Global expansion: Developing markets are starting to adopt remdesivir, driven by supply agreements and price differentiation.
Price Projections
Factors Influencing Price Trends
- Manufacturing Costs: Economies of scale and generic production could reduce prices.
- Regulatory Decisions: Approval of cheaper alternatives or biosimilars would pressure prices downward.
- Market Competition: Entry of oral antivirals such as Paxlovid (Pfizer) lessens demand and could decrease prices.
- Reimbursement Policies: Payer negotiations significantly impact net prices.
Short-term Price Outlook (2023–2025)
| Scenario |
List Price per Course |
Net Price per Course |
Key Drivers |
| Moderate decline |
$3,000 |
$2,400 |
Increased competition, volume discounts |
| Significant decline |
$2,000 |
$1,600 |
Entry of biosimilars, generics, or alternative drugs |
| Stagnation or slight decline |
$3,100 |
$2,500 |
Supply chain stability, limited new competitors |
Long-term Price Outlook (2025+)
Potential for further price reduction to between $1,000 and $2,000 per course if biosimilars or generics are approved, especially in emerging markets. Pricing stability may occur in regions where demand sustains due to ongoing COVID-19 variants.
Regulatory and Policy Impacts
- FDA: No current plans for biosimilar approval for remdesivir; future approval could impact price competition.
- Global Health Initiatives: Negotiations with WHO and UNICEF could flatten global prices, especially in low-income countries.
- Patent Status: Gilead holds patents until 2030; biosimilar development depends on patent litigation outcomes.
Summary of Key Data Points
| Aspect |
Data |
| NDC |
00378-8015 |
| Drug Name |
Remdesivir |
| Manufacturer |
Gilead Sciences |
| Approved Indications |
COVID-19, hospitalized patients |
| 2021 Global Sales |
~$5.4 billion |
| 2021 U.S. Treatment Volume |
~30 million courses |
| List Price (2021) |
~$3,120 per course |
| Estimated Price Decline |
20-45% over next 3 years in some regions |
Key Takeaways
- NDC 00378-8015 (Remdesivir) remains relevant mainly for hospitalized COVID-19 patients.
- Market size is shrinking with the advent of new therapeutics but persists due to ongoing cases and regional needs.
- Prices are expected to decline driven by increased manufacturing capacity, biosimilar entry, and market competition.
- Long-term pricing will depend on patent status, regulatory actions, and global health policies.
FAQs
1. Is remdesivir still under patent protection?
Gilead holds patents until 2030. No biosimilars are currently approved, but patent litigation or expiration could change this.
2. Will prices decline sharply due to biosimilars?
Potentially. Entry of biosimilars typically leads to 30-50% price reductions. However, no biosimilars are authorized yet.
3. How does remdesivir compare to oral antivirals?
Oral drugs like Paxlovid have a competitive advantage due to ease of administration, affecting remdesivir's market share.
4. What regions have the highest demand?
The U.S. accounts for a majority of global demand; some emerging markets are beginning to adopt remdesivir.
5. Are there upcoming regulatory changes that could impact prices?
Pending biosimilar applications and patent disputes are likely to influence future pricing and availability.
Sources
[1] Gilead Sciences. (2022). Gilead reports financial results for fourth quarter and full year 2021.
[2] U.S Food and Drug Administration. (2020). FDA approves first COVID-19 treatment.
[3] WHO. (2022). COVID-19 therapeutics pipeline update.
