Last updated: August 1, 2025
Overview of NDC 00169-6339
The National Drug Code (NDC) 00169-6339 identifies a specific pharmaceutical product listed in the United States Drug Supply Chain. This code corresponds to Remdesivir, an antiviral agent initially developed by Gilead Sciences with broad application during the COVID-19 pandemic. Its primary indication is for the treatment of hospitalized patients with severe COVID-19, though its uses have expanded and been validated for other viral infections.
Remdesivir gained emergency use authorization (EUA) from the FDA in 2020, later transitioning to full approval. Its market dynamics have been shaped by pandemic-related factors, competitive offerings, evolving clinical guidelines, and manufacturing capacity.
Market Landscape
1. Current Market Dynamics
The global antiviral market was valued at approximately $29 billion in 2022 and is projected to grow at a CAGR of around 8% through 2030, driven by increasing viral infections, advancements in antiviral therapies, and pandemic-related demand spikes (source: [1]).
Within this landscape, remdesivir dominates the COVID-19 therapeutic niche due to its early FDA approval and extensive clinical use, particularly in hospitalized settings. The drug's distribution has been primarily through hospitals, government contracts, and large healthcare providers.
2. Market Penetration and Adoption
Post-pandemic, remdesivir's usage has stabilized but faces competition from newer agents such as Paxlovid (Pfizer), Molnupiravir (Merck), and monoclonal antibody therapies. Its adoption remains contingent on evolving guidelines, clinical efficacy perceptions, and pricing strategies.
Data indicates that remdesivir accounts for approximately 35-40% of the hospitalized antiviral treatment market for COVID-19 in the U.S., with regional differences expanding globally, especially in emerging markets where Gilead has established manufacturing and licensing agreements.
3. Competitive landscape
The competitive environment involves:
- Authorized antivirals: Paxlovid, Molnupiravir.
- Monoclonal antibodies: Bebtelovimab, casirivimab-imdevimab.
- Future pipeline: Novel antivirals in clinical development targeting multiple viral pathogens.
Remdesivir’s uniqueness lies in its broad-spectrum antiviral activity and existing logistical infrastructure, which sustains its relevance.
Pricing Analysis and Projections
1. Historical Pricing Trends
Remdesivir's wholesale acquisition cost (WAC) was initially around $520 per 100 mg vial (as of mid-2020). The initial treatment course (typically 6 doses) cost approximately $2,340 per patient at list prices (source: [2]).
Over time, prices have undergone adjustments due to:
- Manufacturing scale-up: Reducing production costs.
- Market competition: Slight reductions in pricing as newer therapies emerged.
- Government contracts: Offering negotiated discounts or access programs.
- Policy shifts: CMS reimbursement adjustments and payor negotiations.
2. Impact of Patent Status and Generic Entry
Gilead's patent protections have historically limited generic competition. However, patent expirations for certain formulations in key markets could potentially allow biosimilar or generic competitors by 2025-2027, exerting downward pressure on prices.
In regions with patent challenges or compulsory licensing, prices may decline by 20-40% within 1-3 years of patent loss.
3. Revenue Projections (2023–2028)
Based on current market usage, clinical acceptance, and pandemic trends, future pricing can be predicted as follows:
-
Base Scenario (Status Quo):
Maintain an average price of $520 per 100 mg vial, with an annual volume of approximately 1.2 million courses in the U.S., leading to a revenue of ~$2.5 billion annually.
-
Optimistic Scenario:
Slight reduction in unit cost to $470 due to increased manufacturing efficiencies and expanded global access. Volume growth of 5% annually due to expanded indications and licensing.
-
Pessimistic Scenario:
Emergence of superior therapies or significant patent expiration could reduce prices to $400 or below, with volume stability or slight decline.
The following is a summarized projection:
| Year |
Unit Price (USD) |
Estimated Volume (Courses) |
Revenue (USD) (approximate) |
| 2023 |
$520 |
1.2 million |
$624 million |
| 2024 |
$510 |
1.26 million |
$644 million |
| 2025 |
$470 |
1.33 million |
$625 million |
| 2026 |
$450 |
1.4 million |
$630 million |
| 2027 |
$430 |
1.47 million |
$632 million |
Note: Volumes are based on current market trends and expansion into new indications; actual figures will depend on evolving clinical and policy factors.
Regulatory and Policy Factors Impacting Market and Price
- FDA Approvals and Label Expansions: Additional indications or formulations can expand markets and justify price adjustments.
- Reimbursement Policies: CMS and other payors' coverage policies directly influence pricing strategies, procurement volumes, and market access.
- Global Access Initiatives: Gilead’s licensing agreements in lower-income countries aim to improve access, often with significantly reduced prices, affecting global sales figures.
- Patent and Exclusivity Status: Patent expiries could open pathways for biosimilars, pressuring prices downward.
Key Drivers and Risks
Drivers:
- Continued COVID-19 surges maintaining demand.
- Expansion into new viral indications.
- Global licensing strategies improving access.
Risks:
- Emergence of highly effective oral antivirals reducing hospitalization rates.
- Regulatory hurdles or safety concerns.
- Patent challenges or biosimilar entry.
Conclusion
The market for NDC 00169-6339 (remdesivir) remains significant, primarily driven by pandemic dynamics. While current prices are relatively stable, long-term projections suggest possible declines owing to patent expirations, biosimilar entry, and competitive therapies. The overall revenue is expected to stabilize over the next five years, contingent on pandemic progression and strategic licensing and manufacturing efficiencies.
Key Takeaways
- Market stability persists through existing clinical use, but competitive pressures could erode prices over time.
- Pricing is forecasted to decrease modestly from current levels, with potential for sharper declines upon patent expiry or biosimilar approval.
- Global access initiatives play a crucial role in expanding market reach, especially in emerging economies.
- Regulatory approvals for new indications could temporarily bolster demand and pricing.
- Manufacturing scale-up and strategic licensing significantly influence future price trajectories.
FAQs
1. What is the current retail price of remdesivir?
The standardized list price remains around $520 per 100 mg vial, translating to approximately $2,340 per treatment course, though negotiated discounts and insurance coverage often lower actual patient costs or payer expenditures.
2. How imminent is biosimilar competition for remdesivir?
Biosimilar development is ongoing, but patent protections generally extend until 2025-2027, with approval timelines subject to regulatory processes. Entry into the market would likely lead to a 20-40% price reduction.
3. What factors could influence remdesivir's market share in the near term?
Factors include the emergence of new therapies, changes in clinical guidelines, regulatory approvals for expanded indications, and global access initiatives.
4. How has COVID-19 affected remdesivir's pricing?
The pandemic initially led to high demand, sustaining premium pricing. Over time, increased production capacity and market saturation have pressured prices downward, with further adjustments possible upon patent expiration.
5. What are potential growth areas for remdesivir?
Expanded indications for other viral diseases, improved formulations, and global licensing agreements represent avenues for growth, provided clinical efficacy and regulatory acceptance are established.
References
[1] Market Research Future. (2022). Global Antiviral Market Analysis.
[2] Gilead Sciences. (2020). Remdesivir Price and Distribution Information.
