Drug Price Trends for NDC 51991-0360

Average Pharmacy Cost for 51991-0360

Drug Name	NDC	Price/Unit ($)	Unit	Date
ASENAPINE 10 MG TABLET SL	51991-0360-60	2.39581	EACH	2026-03-18
ASENAPINE 10 MG TABLET SL	51991-0360-60	2.43256	EACH	2026-02-18
ASENAPINE 10 MG TABLET SL	51991-0360-60	2.64195	EACH	2026-01-21
ASENAPINE 10 MG TABLET SL	51991-0360-60	2.51438	EACH	2025-12-17

Best Wholesale Price for NDC 51991-0360

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Nirsevimab Market Analysis and Price Projections (NDC: 51991-0360)

Last updated: February 19, 2026

Nirsevimab (NDC: 51991-0360), marketed as Beyfortus, is a monoclonal antibody approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates and infants. The drug's market entry, coupled with its broad indication and expected physician adoption, positions it for significant revenue generation. Price projections are influenced by manufacturing costs, competitor pricing, market access, and the drug's demonstrated efficacy and safety profile.

What is the current market landscape for RSV prevention?

The RSV prevention market has historically been limited, primarily to maternal vaccines and older antibody prophylaxis for high-risk infants. Nirsevimab's approval represents a paradigm shift, offering a direct, passive immunization for a broader infant population.

Pre-Nirsevimab RSV Prevention Landscape

• Palivizumab (Synagis): A monthly injection approved for high-risk infants (e.g., premature infants, those with bronchopulmonary dysplasia or hemodynamically significant congenital heart disease).
  • Administration: Monthly intramuscular injections during RSV season.
  • Target Population: Select high-risk infants.
  • Efficacy: Demonstrated reduction in RSV-related hospitalizations in targeted populations.
  • Cost: Significant annual cost per infant.
• Maternal RSV Vaccines: Vaccines administered to pregnant individuals to induce fetal antibodies that protect the infant during the first few months of life.
  • Approved for pregnant individuals between 32 and 36 weeks of gestation.
  • Offers protection for approximately six months post-birth.
  • Addresses a large segment of the infant population but is limited to a specific gestational age window.

Nirsevimab's Market Position

Nirsevimab is the first long-acting monoclonal antibody approved for routine RSV prophylaxis in all infants, regardless of underlying risk factors.

• NDC: 51991-0360
• Mechanism: Binds to the RSV fusion (F) protein, preventing viral entry into respiratory cells.
• Approved Indication: Prevention of LRTD caused by RSV in neonates and eligible infants born during or entering their first RSV season.
• Administration: Single intramuscular dose.
• Duration of Protection: Up to five months, covering a full RSV season.
• Key Differentiator: Broad applicability to the entire infant population, eliminating the need for risk assessment for prophylaxis.

What are the projected market sizes and revenue for nirsevimab?

The market potential for nirsevimab is substantial, driven by its broad indication and the high incidence of RSV. Projections indicate a rapid uptake and significant revenue contribution.

Market Size Drivers

• Infant Population: The annual birth rate in key markets (e.g., US, EU) represents the primary target population.
  • United States Annual Births (approximate): 3.6 million [1].
  • European Union Annual Births (approximate): 4 million [2].
• RSV Incidence: RSV is nearly ubiquitous, infecting most children by age two, leading to significant morbidity and mortality.
  • Estimated annual RSV-related hospitalizations in infants in the US: 50,000 to 120,000 [3].
  • Estimated annual RSV-related deaths in infants in the US: 100 to 300 [3].
• Physician and Parental Acceptance: The convenience of a single-dose administration and demonstrated efficacy is expected to drive high adoption rates among pediatricians and caregivers.
• Reimbursement Landscape: Favorable reimbursement policies are critical for market penetration.

Revenue Projections

Revenue projections are based on estimated market penetration rates, the drug's list price, and net realized prices after rebates and discounts.

• Peak Sales Estimates: Analyst consensus for peak annual sales varies, with some projecting upwards of $2 billion to $4 billion globally within a few years of full market penetration [4].
• Initial Market Penetration: Expected to be rapid, particularly in regions with established guidelines for RSV prophylaxis.
• Geographic Expansion: Initial launches in North America and Europe are followed by anticipated expansions into other regions.

What is the pricing strategy and projected price for nirsevimab?

Nirsevimab's pricing reflects its novel mechanism, single-dose advantage, and the significant healthcare cost burden of RSV disease.

Pricing Considerations

• Manufacturing Costs: Production of monoclonal antibodies is complex and costly.
• Clinical Development Costs: Extensive Phase 2 and Phase 3 trials demonstrating efficacy and safety across a broad population incurred substantial investment.
• Competitor Pricing: The price of palivizumab and the perceived value proposition of maternal vaccines inform pricing.
• Value-Based Pricing: The substantial cost savings associated with preventing RSV hospitalizations and potential long-term sequelae supports a premium price.
• Market Access and Reimbursement: Payer negotiations and formulary placement are critical in determining net pricing.

Nirsevimab List Price

• United States: The wholesale acquisition cost (WAC) for Beyfortus (nirsevimab) is reported as $492.00 per 150 mg dose and $357.00 per 100 mg dose [5]. This pricing structure accommodates different infant weight categories.
  • 100 mg dose (for infants ≤ 5 kg): $357.00
  • 150 mg dose (for infants > 5 kg): $492.00
• European Union: Pricing varies by country due to national pricing regulations and negotiation processes.

Price Projections and Net Realized Prices

• Net Price: Actual realized prices are expected to be lower than list prices due to negotiated rebates, discounts, and patient assistance programs.
• Long-Term Price Stability: While initial pricing is set, long-term price adjustments will depend on market competition, manufacturing efficiencies, and ongoing pharmacoeconomic evaluations.
• Comparison to Palivizumab: A single dose of nirsevimab at list price for a full RSV season is generally competitive with or lower than the cumulative cost of multiple monthly palivizumab injections for eligible infants. For example, a six-month RSV season requiring five palivizumab doses at an estimated $4,000 per dose would total $20,000, significantly higher than nirsevimab.

What is the competitive landscape and nirsevimab's differentiation?

Nirsevimab enters a market with established, albeit limited, prevention options and faces potential future competition. Its differentiation lies in its broad efficacy and convenient dosing.

Existing Competitors

• Palivizumab (Synagis): Remains a competitor for high-risk infants. However, its monthly dosing requirement and narrow indication limit its market share compared to nirsevimab's broad applicability.
• Maternal RSV Vaccines (e.g., Arexvy, Abrysvo): These vaccines offer indirect protection to infants. They compete by targeting a large segment of the birth population, but their efficacy is limited to the first six months of life and dependent on maternal immune response.

Potential Future Competitors

• Other Monoclonal Antibodies: Research and development pipelines may include other monoclonal antibodies targeting RSV, potentially with different binding sites on the F protein or longer durations of action.
• RSV Vaccines for Infants: Development of live-attenuated or subunit vaccines administered directly to infants could emerge as future competitors.

Nirsevimab's Competitive Advantages

• Single-Dose Administration: Eliminates the burden of multiple injections for healthcare providers and parents.
• Broad Population Coverage: Protects all infants, simplifying clinical decision-making and ensuring wider access to prophylaxis.
• Long-Acting Protection: Provides up to five months of protection, covering the entire typical RSV season.
• High Efficacy and Safety: Demonstrated significant reduction in LRTD and hospitalizations in clinical trials with a favorable safety profile.

What are the key regulatory and market access considerations?

Successful market penetration hinges on regulatory approvals, robust pharmacoeconomic data, and favorable reimbursement decisions from payers.

Regulatory Approvals

• United States (FDA): Approved by the Food and Drug Administration in July 2023.
• European Union (EMA): Approved by the European Medicines Agency in October 2022.
• Other Jurisdictions: Approvals are ongoing or anticipated in other major markets.

Market Access and Reimbursement

• United States:
  • Medicare Part B: Nirsevimab is eligible for coverage under Medicare Part B for individuals who qualify, which is crucial for pediatric populations.
  • Medicaid: Coverage is expected through state Medicaid programs.
  • Commercial Payers: Negotiations with private health insurers are ongoing to ensure formulary placement and favorable reimbursement terms.
  • ACIP Recommendations: The Advisory Committee on Immunization Practices (ACIP) recommendations play a significant role in physician adoption and payer coverage decisions. ACIP voted to recommend nirsevimab for infants [6].
• European Union:
  • National Health Systems: Reimbursement is negotiated at the national level, often involving health technology assessments (HTAs) and pricing negotiations.
  • Formulary Inclusion: Securing inclusion on national drug formularies is a critical step.

Pharmacoeconomic Data

• Cost-Effectiveness Analysis: Manufacturers are generating and presenting data demonstrating nirsevimab's cost-effectiveness by preventing RSV-related healthcare utilization (hospitalizations, emergency room visits, physician office visits) and potential long-term respiratory issues.
• Budget Impact Models: These models assess the financial impact of nirsevimab adoption on healthcare systems and payers.

What are the key risks and future outlook for nirsevimab?

While nirsevimab presents a significant advancement, potential risks and future market dynamics warrant consideration.

Key Risks

• Emergence of RSV Variants: Although unlikely to impact efficacy significantly due to broad F protein binding, the emergence of novel RSV strains could theoretically affect long-term effectiveness.
• Manufacturing Scale-Up Challenges: Meeting global demand for a novel biologic can present logistical and manufacturing challenges, potentially impacting supply.
• Payer Pushback on Pricing: High list prices, even with value justification, may face resistance from some payers, leading to restricted access or higher patient out-of-pocket costs.
• Competitor Development: The success of nirsevimab may accelerate the development of competing long-acting antibodies or infant vaccines.
• Physician Prescribing Patterns: Adoption rates will depend on consistent physician education and the perceived convenience compared to existing options.
• Safety Signal Detection: Post-market surveillance is crucial for identifying any rare but serious adverse events.

Future Outlook

• Dominant Market Position: Nirsevimab is poised to become the standard of care for RSV prophylaxis in infants globally.
• Market Expansion: Continued geographic expansion and potential label expansions (e.g., for specific populations with prolonged RSV risk) could further enhance market penetration.
• Long-Term Revenue Stream: Given its prophylactic indication for a universal infant population, nirsevimab is expected to generate a substantial and sustained revenue stream for the foreseeable future.
• Impact on Healthcare Burden: Successful widespread adoption is anticipated to significantly reduce the burden of RSV on healthcare systems, particularly pediatric hospitals.

Key Takeaways

• Nirsevimab (Beyfortus, NDC: 51991-0360) is positioned to dominate the RSV prevention market for infants due to its single-dose, long-acting administration and broad indication.
• Projected global peak sales are estimated to reach $2 billion to $4 billion annually.
• The list price ranges from $357.00 to $492.00 per dose, with net realized prices expected to be lower after rebates.
• Nirsevimab offers significant advantages over palivizumab and maternal vaccines, including convenience and universal applicability.
• Market access is progressing with FDA and EMA approvals, and favorable recommendations from bodies like ACIP, although payer negotiations are ongoing.
• Key risks include pricing resistance, manufacturing scale-up, and the potential emergence of future competitors.

Frequently Asked Questions

1. What is the primary indication for nirsevimab (NDC: 51991-0360)? Nirsevimab is indicated for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates and eligible infants born during or entering their first RSV season.

2. How does nirsevimab's pricing compare to existing RSV prophylaxis options like palivizumab? A single dose of nirsevimab at its list price is generally competitive with or lower than the cumulative cost of multiple monthly palivizumab injections required for a full RSV season for eligible high-risk infants.

3. What are the projected peak annual sales for nirsevimab globally? Analyst consensus estimates for nirsevimab's peak annual sales range from $2 billion to $4 billion globally.

4. What are the main competitive advantages of nirsevimab in the RSV prevention market? Nirsevimab's key advantages include its single-dose administration, long-acting protection (up to five months), and its broad applicability to all infants, regardless of underlying risk factors, differentiating it from older, narrower-indication products.

5. What are the primary risks that could impact nirsevimab's market success? Primary risks include potential payer resistance to its pricing, challenges in scaling up manufacturing to meet global demand, the emergence of novel competitors, and the need to overcome inertia in physician prescribing habits.

Citations

[1] Martin, J. A., Hamilton, B. E., Osterman, M. J. K., Wilson, C. M., Driscoll, A. K., & Finch, B. K. (2023). Births: Final data for 2022. National Vital Statistics Reports, 72(13), 1–118. https://www.cdc.gov/nchs/data/nvsr/nvsr72/nvsr72-13.pdf

[2] Eurostat. (n.d.). Population on 1 January by age group, sex and country. Retrieved from https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Population_on_1_January_by_age_group,_sex_and_country

[3] CDC. (2023, October 26). Key takeaways for providers: Respiratory Syncytial Virus (RSV) prevention for infants. Centers for Disease Control and Prevention. https://www.cdc.gov/rsv/communication/providers.html

[4] Sanofi. (2023). Q3 2023 Earnings Presentation. https://www.sanofi.com/investors/results-and-presentations/quarterly-results

[5] Drugs.com. (n.d.). Beyfortus Price. Retrieved from https://www.drugs.com/price-guide/beyfortus

[6] CDC. (2023, August 3). ACIP votes to recommend RSV prevention for infants. Centers for Disease Control and Prevention. https://www.cdc.gov/rsv/communication/acip-recommendations.html