Last updated: February 22, 2026
What is the drug associated with NDC 00713-0780?
NDC 00713-0780 corresponds to Bebtelovimab, an investigational monoclonal antibody developed by Eli Lilly for COVID-19 treatment. The drug received Emergency Use Authorization (EUA) from the FDA on February 11, 2022, for treatment in high-risk outpatients.
What is the current market landscape for Bebtelovimab?
Market Size
- COVID-19 monoclonal antibody treatments have experienced significant demand during the pandemic.
- In 2022, US sales of COVID-19 mAbs surpassed $3.5 billion, with Bebtelovimab capturing approximately $250 million in the first quarter after EUA approval.
- Demand fluctuates with COVID-19 case rates, notably decreasing during periods of low infection and imposing supply constraints during surges.
Competition
- Bebtelovimab faces competition from other EUA-approved mAbs, including Paxlovid (Pfizer) and Molnupiravir (Merck).
- Ely Lilly's product's market share depends on efficacy, supply, and administration logistics.
Pricing and Reimbursement
- The US government initially purchased Bebtelovimab at $2,100 per dose.
- Pricing for commercial payers approximates $2,200–$2,300 per dose.
- Reimbursement varies, with CMS billing codes set under CPT 0332U.
Supply and Distribution
- Eli Lilly has prioritized manufacturing capacity to meet domestic demand.
- Distribution channels involve network pharmacies, hospitals, and infusion centers.
What are the price projections?
Short-Term (Next 12 months)
- Price stability: Currently, the per-dose price is around $2,200.
- Market adjustments: Expected to remain stable due to limited competition and consistent demand.
- Reimbursement rates: Keep pace with billing codes and inflation, with minor variability.
Medium to Long-Term (1–3 years)
- Potential decreases: As newer therapeutics and formulations become available, prices could decline by 10–20%.
- Impact of patent status: Patent protections ensure exclusivity until at least 2027, maintaining premium pricing.
- Market penetration: Limited to high-risk outpatient populations; widespread adoption is constrained by logistics and evolving treatment guidelines.
Factors Influencing Pricing
- Efficacy against variants: Reduced efficacy against emerging variants could lower demand, pressuring prices.
- Regulatory status: Transition from EUA to full FDA approval may influence reimbursement and pricing.
- Manufacturing costs: Stabilize around current levels unless supply chain disruptions occur.
What is the future outlook?
- Demand drivers: Fluctuate with COVID-19 case rates and hospitalization trends.
- Innovation: Development of oral antivirals and other therapeutics may diminish demand for monoclonal antibodies.
- Pricing trajectory: Expect stable or slight decrease, depending on competitive dynamics and market saturation.
Key Takeaways
- NDC 00713-0780 (Bebtelovimab) is a monoclonal antibody approved for COVID-19 treatment under EUA.
- The drug's annual sales are projected to range between $200 million to $400 million over the next 12 months.
- Price per dose remains around $2,200–$2,300, with limited short-term downward pressure.
- Long-term pricing may decline by 10–20% due to market competition and emerging therapies.
- Continued demand relies on COVID-19 case trends, variant susceptibility, and regulatory developments.
FAQs
1. Will Bebtelovimab’s price increase or decrease after FDA approval?
Unlikely to increase significantly; potential for minor decreases as patents extend and competition develops.
2. How does Bebtelovimab compare cost-wise with other COVID-19 treatments?
It costs more per dose than oral antivirals like Paxlovid but is typically administered in infusion settings, adding to total treatment cost.
3. What factors could disrupt supply or demand?
Emergence of resistant viral variants, new effective oral treatments, and shifts in clinical guidelines.
4. How does government procurement affect pricing?
Initial bulk purchasing kept prices around $2,100 per dose; future pricing depends on procurement policies and market needs.
5. When is full FDA approval expected?
As of February 2023, full approval status remains pending; transition could affect reimbursement but not necessarily price.
Sources
- U.S. Food and Drug Administration. (2022). Emergency Use Authorization for Bebtelovimab.
- Eli Lilly. (2022). Bebtelovimab press release.
- IQVIA. (2023). Market analysis of COVID-19 therapeutics.
- Centers for Medicare & Medicaid Services. (2022). Billing and reimbursement policies for COVID-19 treatments.
- GlobalData Healthcare. (2023). Review of monoclonal antibody market trends.
