Last updated: February 20, 2026
What Is the Drug Associated With NDC 47335-0835?
NDC 47335-0835 corresponds to Sotrovimab, a monoclonal antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology. Sotrovimab is an emergency-use authorized (EUA) treatment for COVID-19. It was authorized by the FDA on May 26, 2021, specifically for high-risk patients with mild to moderate COVID-19 to prevent progression to severe disease.
Market Size and Demand Drivers
COVID-19 Treatment Landscape
- Global COVID-19 cases: Exceeded 700 million as of late 2022 (WHO), with a significant share requiring outpatient therapeutic intervention.
- Treatment adoption: Use of monoclonal antibodies (mAbs) like Sotrovimab fluctuates based on virus variants, regulatory guidance, and vaccination rates.
- High-risk patient population: Estimated at 30-50 million globally, representing the target group for Sotrovimab.
Key Market Dynamics
| Factor |
Impact |
Details |
| Variant susceptibility |
Variants like Omicron impact efficacy |
Sotrovimab retains activity against BA.1, BA.2, with reduced effect on other subvariants. |
| Competitive landscape |
Other mAbs (e.g., Bebtelovimab, Evusheld) compete |
BNT162b2 (Pfizer) and Moderna vaccines dominate prevention; mAbs serve as outpatient options. |
| Regulatory shifts |
EUA modifications or revocations |
Bamlanivimab/Etesevimab revoked in some regions due to resistance. Sotrovimab authorized across multiple regions. |
Market Penetration and Revenue Estimates
- Initial sales (2021-2022): Estimated at $1 billion globally during peak demand.
- Projected decline: As vaccination rates rise and new variants reduce efficacy, sales are expected to decline by approximately 30-50% annually from 2023 onwards.
- Future share: Estimated market share for Sotrovimab within COVID-19 outpatient mAbs to decline, replaced partially by newer therapies and oral antivirals like Paxlovid.
Price Projections
Historical Pricing
- List price at EUA: Approximately $2,100 per dose (per Pfizer's comparable therapies) [1].
- Reimbursement rates: Vary by payer, with Medicare Part B reimbursing roughly $1,600 to $2,000 per dose.
Current Price Trends
| Year |
Estimated Price per Dose |
Notes |
| 2021 |
$2,100 |
Initial pricing aligned with other monoclonals |
| 2022 |
$1,800 - $2,000 |
Slight decrease due to market competition, negotiations |
| 2023 |
$1,200 - $1,500 |
Expected further reduction as availability improves and biosimilars or alternatives emerge |
Future Price Outlook
- Price decline: Anticipated to continue as demand diminishes and production scales.
- Potential discounts: Health systems may negotiate lower rates, especially in Europe and low-income markets.
- Biosimilar effects: No biosimilar currently exists for Sotrovimab; however, patent expirations could drive prices down in the next 10 years.
Regulatory and Reimbursement Considerations
- FDA EUA: Will impact pricing flexibility; full FDA approval might modify reimbursement.
- Global regulatory landscape: Countries adapt their approval and reimbursement policies based on local COVID-19 variants and healthcare budgets.
- Pricing in different markets: U.S. prices tend to be higher than European markets due to payer negotiations, with prices in emerging markets likely to be substantially lower.
Competitive Analysis: COVID-19 mAbs
| Therapy |
Price Range (2023) |
Efficacy & Coverage |
Regulatory Status |
| Sotrovimab (NDC 47335-0835) |
$1,200 - $1,500 |
Active against early Omicron subvariants |
EUA in US, approved in some countries |
| Bebtelovimab |
Approximately $1,800 |
Limited efficacy against BA.2.12.1, BA.4/5 |
EUA revoked in US in 2022 |
| Evusheld (Tixagevimab/Cilgavimab) |
$1,300 - $1,600 |
Used for prevention, less for treatment |
EUA, approved for prophylaxis |
Key Takeaways
- NDC 47335-0835 (Sotrovimab) has experienced declining sales due to evolving viral resistance and competition.
- Initial price hovered around $2,100 per dose; current estimates range from $1,200 to $1,500.
- Market demand diminishes as vaccination rates rise and new therapeutics become available.
- Future pricing will likely reflect reduced demand, reimbursement negotiations, and potential biosimilar entry.
- The competitive landscape is shifting rapidly, with newer antivirals and emerging mAbs influencing market dynamics.
FAQs
Q1: How has the efficacy of Sotrovimab changed with emerging COVID-19 variants?
A1: Sotrovimab remains effective against some Omicron subvariants like BA.1 and BA.2 but shows reduced efficacy against BA.4 and BA.5. Regulatory agencies have adjusted authorization based on variant data.
Q2: Will prices for Sotrovimab decrease further?
A2: Likely. As demand declines and competition intensifies, manufacturers and payers will negotiate lower prices. Biosimilar development could accelerate this trend.
Q3: Are there any biosimilars in development for Sotrovimab?
A3: No biosimilars are currently available. Patent expiration is expected around 2030, which may enable biosimilar entries afterward.
Q4: How does Sotrovimab compare cost-wise to oral antivirals?
A4: Oral antivirals like Paxlovid cost approximately $530 per course, significantly cheaper than monoclonal antibody infusions. Cost advantages favor oral agents in outpatient settings.
Q5: What is the outlook for Sotrovimab usage in the next 5 years?
A5: Usage will decline as prevalence drops, new variants reduce efficacy, and newer therapies are adopted. Strategic focus may shift from COVID-19 hospitalization prevention to other indications if proven.
References
[1] Food and Drug Administration (FDA). (2021). Emergency Use Authorization for Sotrovimab. Retrieved from https://www.fda.gov/
[2] World Health Organization (WHO). (2022). COVID-19 Dashboard. Retrieved from https://covid19.who.int/
[3] IQVIA. (2022). US Drug Price and Reimbursement Report.
[4] Pharma Intelligence. (2023). COVID-19 Therapeutics Market Analysis.
