Last updated: February 25, 2026
What is NDC 00113-0825?
The National Drug Code (NDC) 00113-0825 refers to a specific pharmaceutical product. According to the FDA database and publicly available drug registries, this NDC identifies Remdesivir injection (Veklury), used for treating COVID-19. It is manufactured primarily by Gilead Sciences.
Market Size and Demand Dynamics
COVID-19 Therapeutic Landscape
Remdesivir gained Emergency Use Authorization in May 2020, later receiving full FDA approval in October 2020. It became a standard treatment for hospitalized COVID-19 patients. On the global scale, the demand peaked in 2021 and has gradually declined with the emergence of new variants and vaccination efforts.
Global Sales and Utilization
- In 2021, Gilead reported $5.62 billion in remdesivir sales.
- US sales represented approximately 60% of total global revenue.
- The drug’s utilization is linked with COVID-19 hospitalization rates, which vary with infection waves.
Key Market Segments
- Hospitals and healthcare facilities are primary purchasers.
- Government agencies stockpile and distribute remdesivir, affecting procurement patterns.
- Emerging markets are increasing local procurement, influenced by global health initiatives.
Competitive Environment
Market Participants
- Gilead Sciences (original manufacturer)
- Contract manufacturers producing licensed biosimilars
- Pending biosimilar entrants from companies in India and China
Biosimilar Development
- Multiple biosimilar candidates are in development or early approval stages.
- The biosimilar landscape could impact Gilead’s pricing by increasing competition.
Regulatory and Patent Considerations
- Gilead maintains patents expiring around 2025 in the US.
- Patent expirations could open the market for biosimilar competition.
Price Projections
Current Pricing (as of Q1 2023)
- Wholesale acquisition cost (WAC): Approximately $390 per 100 mg
- A typical course involves 6 vials, totaling $2,340.
- Hospital negotiated prices tend to be lower, with discounts around 10-20%.
Short-term Price Outlook (2023-2025)
- Prices remain relatively stable due to limited biosimilar competition.
- No significant price erosion expected until patent expiry or biosimilar approval.
- Gilead may optimize pricing for new formulations or expanded indications.
Long-term Price Dynamics (Post-2025)
- Biosimilar entry likely to reduce prices by 20-40%.
- Increased manufacturing efficiencies and competition could accelerate price declines.
- Pricing could stabilize at $150-$200 per course upon biosimilar market entry.
External Factors Impacting Price
- Changes in regulatory policies or reimbursement frameworks.
- Volatility in COVID-19 hospitalization rates.
- Global supply chain factors influencing manufacturing costs.
Revenue Projections for Gilead
| Year |
Estimated Global Sales |
Notes |
| 2023 |
$2.0 billion |
Stabilization at current pricing levels |
| 2024 |
$1.5 billion |
Slight decline, as demand softens |
| 2025 |
$1.2 billion |
Pre-biosimilar competition, nearing patent expiry |
| 2026+ |
$300 million - $600 million |
Potential biosimilar market entry |
Strategic Considerations
- Gilead may pursue licensing or alliance agreements to delay biosimilar competition.
- Expanding indications (e.g., other viral infections) can sustain revenue.
- Developing next-generation formulations could impact pricing and market share.
Key Takeaways
- The market for NDC 00113-0825 centers on COVID-19 treatment, with substantial sales in 2021.
- Prices are stable currently, with limited biosimilar competition until 2025.
- Future pricing likely to decline significantly after patent expiry, aligning with biosimilar market entry.
- The demand is sensitive to COVID-19 infection rates, vaccination progress, and emerging variants.
- Strategic patent protections and new indications could influence revenue trajectories beyond 2025.
FAQs
1. Will the price of remdesivir decrease before patent expiration?
Current prices are stable due to limited biosimilar competition. Price reductions are unlikely until biosimilar approval and market entry, expected around 2025.
2. How does biosimilar entry affect the market?
Biosimilars typically reduce prices by 20-40%. They increase market competition, which can lead to lower consumer costs and impact Gilead's revenue.
3. What other indications could extend remdesivir’s market?
Potential uses in other viral infections or expanded COVID-19 treatment protocols may sustain demand and delay revenue decline.
4. How have global vaccination efforts impacted remdesivir demand?
Vaccination reduces severe COVID-19 cases, decreasing hospitalizations and lower demand for remdesivir in the long term.
5. What strategies could Gilead employ to maintain market share?
Gilead can develop new formulations, expand indications, or negotiate licensing to delay biosimilar competition.
References
[1] U.S. Food and Drug Administration. (2022). Veklury (Remdesivir) approval and labeling information. https://www.fda.gov
[2] Gilead Sciences. (2022). Gilead FY2021 Annual Report. https://www.gilead.com/investors
[3] IQVIA. (2022). The Global Use of Medicines in 2022. IQVIA Institute.
