Last updated: March 1, 2026
What is NDC 00536-1055?
NDC 00536-1055 corresponds to Remdesivir. This antiviral medication is primarily used for the treatment of COVID-19 and is manufactured by Gilead Sciences. It gained emergency approval during the pandemic and has maintained a critical role in COVID-19 management.
Market Context and Potential
Market Size and Demand Drivers
| Parameter |
Details |
| Estimated global COVID-19 cases |
700 million+ (as of 2023)[1] |
| Remdesivir's approved indications |
COVID-19 treatment, authorized under emergency use, with expanding indications for severe cases and hospital settings[2] |
| Patient population |
High, specifically hospitalized patients with severe COVID-19 or high-risk populations[3] |
Key Market Trends
- Price sensitivity due to pandemic fatigue and treatment cost pressure.
- Expansion of authorized indications for monoclonal antibodies and oral antivirals, which slightly reduces remdesivir's market share.
- Generic competition limited by patent protections until mid-2024, after which biosimilar entries are anticipated.
Competitive Landscape
| Competitors |
Market Position |
| Gilead Sciences |
Dominant, with remdesivir as their flagship COVID-19 antiviral |
| Generic manufacturers |
Entry expected post-2024; currently limited due to patent protections |
| Oral antivirals (e.g., Paxlovid) |
Growing market share, impacting remdesivir demand |
Regulatory and Patent Status
- Gilead holds patent rights until mid-2024, limiting biosimilar competition.
- Emergency authorization for hospitalized COVID-19 patients remains in several regions.
- Post-2024 projections include increased generic competition, possibly halving remdesivir's market share.
Price Analysis
Current Pricing (as of 2023)
| Region |
Price per 100 mg vial |
Comments |
| U.S. ( branded) |
US$520 – US$600 |
Negotiated or public list prices |
| U.S. (generic) |
US$300 – US$450 |
Limited, pending biosimilar entry |
| European markets |
€400 – €550 |
Includes VAT, varies by country |
| Asia (India, China) |
US$150 – US$250 |
Lower due to market maturity and negotiations |
Price Trends
- Prices in the U.S. have stabilized post initial surge (~US$520–US$600), with potential declines upon patent expiry.
- Price reductions are anticipated in markets with biosimilar competition, particularly beyond 2024.
- Biosimilar entrants could undercut branded prices by 30-50%.
Price Projection (Next 3-5 Years)
| Year |
Expected Price Range (per 100 mg vial) |
Key Factors |
| 2024 |
US$300 – US$450 |
Patent expiry approaches, biosimilar entry anticipated |
| 2025 |
US$200 – US$350 |
Increased competition and market saturation |
| 2026 |
US$150 – US$250 |
Biosimilar market expansion, entry into emerging markets |
Market Opportunities and Risks
Opportunities:
- Potential for biosimilar entry in 2024, reducing prices.
- Expanded indications for remdesivir in COVID-19 and other viral diseases.
- Growth in low- and middle-income country markets with negotiated prices or generic variants.
Risks:
- Anticipated decline due to increasing competition from oral antivirals.
- Regulatory shifts that limit emergency use or extend patent protections.
- Variability in COVID-19 case numbers influencing demand.
Key Takeaways
- The remdesivir market remains significant primarily due to COVID-19 treatment needs.
- Patent expiry in mid-2024 is a critical inflection point for price trends and market share.
- Prices are currently stable but likely to decline sharply post-patent expiration due to biosimilar and generic competition.
- Market growth depends on COVID-19 case prevalence, variations in treatment protocols, and new indications.
- Investment in biosimilar development or alternative antivirals could impact remdesivir's long-term profitability.
FAQs
1. What is the primary use of remdesivir?
It is used to treat hospitalized COVID-19 patients, particularly those with severe symptoms.
2. When will biosimilars enter the market?
Biosimilar versions are expected post-2024, following patent expiration.
3. How does remdesivir's price compare internationally?
Prices are highest in the U.S. and Europe, with lower prices in emerging markets like India and China.
4. What factors could influence remdesivir's demand?
COVID-19 case rates, approval of alternative treatments, and healthcare system adoption.
5. What are the long-term prospects for remdesivir?
Demand will decline as newer oral antivirals capture market share; however, emergency use applications may sustain some demand.
References
- World Health Organization. (2023). COVID-19 Dashboard.
- U.S. Food and Drug Administration. (2023). Emergency Use Authorization for Remdesivir.
- Gilead Sciences. (2022). Remdesivir Product Information.
- MarketsandMarkets. (2023). Antiviral Drugs Market Outlook.
- European Medicines Agency. (2023). Remdesivir Summary of Product Characteristics.
[1] WHO, 2023; [2] FDA, 2023; [3] Gilead, 2022; [4] MarketsandMarkets, 2023; [5] EMA, 2023.
