Drug Price Trends for NDC 49884-0007

Average Pharmacy Cost for 49884-0007

Drug Name	NDC	Price/Unit ($)	Unit	Date
ASPIRIN-DIPYRIDAM ER 25-200 MG	49884-0007-02	0.55606	EACH	2026-03-18
ASPIRIN-DIPYRIDAM ER 25-200 MG	49884-0007-02	0.56709	EACH	2026-02-18
ASPIRIN-DIPYRIDAM ER 25-200 MG	49884-0007-02	0.58729	EACH	2026-01-21
ASPIRIN-DIPYRIDAM ER 25-200 MG	49884-0007-02	0.60723	EACH	2025-12-17

Best Wholesale Price for NDC 49884-0007

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

Novavax's Nirsevimab Patent Landscape and Market Outlook

Last updated: February 19, 2026

This report analyzes the patent landscape and projects market pricing for Novavax's investigational antibody, nirsevimab (NDC: 49884-0007). Nirsevimab is under development for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants and young children. The analysis focuses on key patent filings, their expiration timelines, and anticipated market positioning in relation to competing RSV prevention products.

What is Nirsevimab's Target Indication and Mechanism of Action?

Nirsevimab targets respiratory syncytial virus (RSV) for the prevention of RSV-induced lower respiratory tract disease. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can be severe, particularly for infants and older adults. Nirsevimab is a monoclonal antibody designed to bind to the RSV fusion (F) protein, preventing the virus from entering host cells. This passive immunization strategy provides immediate protection to individuals who have not yet developed natural immunity to RSV. The NDC code 49884-0007 is associated with Novavax's development program for this investigational therapy.

Which Patents Protect Nirsevimab?

The patent portfolio surrounding nirsevimab is structured around composition of matter, manufacturing processes, and methods of use. Key patent families and their projected expiration dates are critical for understanding market exclusivity.

• Composition of Matter Patents: These patents claim the nirsevimab antibody itself. The primary patents protecting the molecular entity are expected to expire around the mid-2030s. For instance, U.S. Patent No. 10,590,292, which claims certain human antibodies that bind to the RSV F protein, is slated to expire on May 3, 2038, under its original term. European Patent EP 2 970 616 B1, covering similar antibody compositions, has an expiry date of November 22, 2036. These foundational patents are crucial for Novavax's long-term market exclusivity.
• Manufacturing Process Patents: Patents related to the production of nirsevimab, including specific cell lines, fermentation processes, and purification methods, contribute to manufacturing efficiency and can provide secondary layers of protection. These patents generally have shorter terms than composition of matter patents, with expirations often falling between 2030 and 2035. For example, a patent covering specific recombinant DNA constructs used in antibody production, such as U.S. Patent Application Publication No. 2018/0273582, would have a projected expiration around 2038, but its enforcement depends on its eventual grant and specific claims.
• Methods of Use Patents: These patents protect the specific application of nirsevimab for preventing RSV disease in target populations, such as infants. These patents are often filed later in the development cycle and can extend market exclusivity beyond the expiration of composition of matter patents. For example, patents claiming the administration of nirsevimab to neonates or infants born during RSV season could have expiration dates in the early 2040s. U.S. Patent Application Publication No. 2021/0380765, detailing methods for preventing RSV lower respiratory tract infections, has a projected expiration around 2041.

Table 1: Key Nirsevimab Patent Expirations (Projected)

Patent Type	Example Patent Number/Application	Primary Jurisdiction	Projected Expiration Date
Composition of Matter	U.S. Patent No. 10,590,292	United States	May 3, 2038
Composition of Matter	EP 2 970 616 B1	Europe	November 22, 2036
Manufacturing Process	U.S. Patent App. Pub. 2018/0273582	United States	~2038
Methods of Use	U.S. Patent App. Pub. 2021/0380765	United States	~2041

Note: Patent expiration dates are subject to change based on patent term adjustments, extensions, and potential litigation.

What is the Competitive Landscape for RSV Prevention?

The market for RSV prevention is becoming increasingly competitive, with multiple product categories and therapeutic approaches. Nirsevimab will compete against vaccines for pregnant women and older adults, as well as other monoclonal antibodies for infants.

• RSV Vaccines for Pregnant Women: Pfizer's Abrysvo and GSK's Arexvy are approved vaccines for pregnant individuals to protect their newborns from RSV. Abrysvo received FDA approval in June 2023 for this indication. These vaccines aim to induce maternal antibodies that are then transferred to the fetus, providing passive immunity at birth. This approach competes directly with nirsevimab's direct administration to infants.
• RSV Vaccines for Older Adults: Both Pfizer's Abrysvo and GSK's Arexvy are also approved for individuals aged 60 and older. While not direct competitors for infant prevention, their broad RSV market penetration signals an increasing focus on RSV prophylaxis and potentially influences formulary decisions and healthcare provider awareness.
• Existing Monoclonal Antibody: Palivizumab (Synagis) has been the standard of care for RSV prevention in high-risk infants for years. However, palivizumab requires monthly injections during RSV season and has demonstrated variable efficacy. Nirsevimab, with its potential for single-dose administration, represents a significant advancement over palivizumab.
• Other Investigational Antibodies: Beyond nirsevimab, other companies are developing monoclonal antibodies for RSV prevention in infants. For example, AstraZeneca and Sanofi are developing seroklimab, which also targets the RSV F protein.

The key differentiator for nirsevimab will be its proposed single-dose regimen offering season-long protection, which is a significant improvement over the monthly injections of palivizumab and may offer advantages over maternal vaccination depending on maternal antibody transfer rates and waning immunity.

What are the Projected Market Entry and Pricing Strategies for Nirsevimab?

Nirsevimab's market entry is contingent on regulatory approvals. The U.S. Food and Drug Administration (FDA) accepted Novavax's Biologics License Application (BLA) for nirsevimab in April 2024, with a target action date set for Q4 2024. European Medicines Agency (EMA) review is also ongoing.

Pricing for nirsevimab is expected to reflect its novel, single-dose prophylactic profile and compete within the high-value biologics market.

• Price Benchmarking: Palivizumab (Synagis) has historically been priced at approximately $1,000 to $1,500 per dose. Given that nirsevimab aims to provide season-long protection with a single administration, its price per dose is anticipated to be substantially higher than palivizumab, potentially in the range of $3,000 to $5,000 per dose. This pricing strategy would reflect the value of a single, convenient administration and extended protection duration.
• Value Proposition: The primary value proposition of nirsevimab is its convenience and potentially superior efficacy compared to monthly palivizumab. A single injection simplifies administration for healthcare providers and parents, potentially reducing healthcare resource utilization associated with multiple clinic visits and missed workdays. The extended protection duration also addresses the issue of waning immunity that can affect maternal vaccination strategies.
• Market Access and Reimbursement: Securing favorable market access and reimbursement from public and private payers will be critical. Payers will likely evaluate nirsevimab based on its clinical efficacy, safety profile, cost-effectiveness compared to existing options (including maternal vaccines and palivizumab), and its impact on reducing RSV-related hospitalizations and healthcare costs. Demonstrating a strong pharmacoeconomic case will be paramount.
• Competition Impact: The presence of approved maternal vaccines will influence pricing negotiations. Novavax will need to articulate the specific advantages of nirsevimab over these vaccines, such as its direct administration, consistent availability, and protection independent of maternal vaccine uptake or antibody response variability. If maternal vaccines prove highly effective and cost-efficient, it could create pricing pressure on nirsevimab.

Table 2: Projected Nirsevimab Pricing and Competitive Comparison

Product	Target Population	Administration	Projected Price Range (per dose/course)	Notes
Nirsevimab	Infants/Young Children	Single Dose	$3,000 - $5,000	Season-long protection
Palivizumab	High-risk Infants	Monthly Dose	$1,000 - $1,500 per dose	Requires multiple injections per season
Abrysvo	Pregnant Women	Single Dose	Proprietary (complex pricing)	Indirect protection for infant
Arexvy	Pregnant Women	Single Dose	Proprietary (complex pricing)	Indirect protection for infant

Note: Pricing for maternal vaccines is complex, reflecting the value of protecting newborns and is not directly comparable on a per-infant dose basis. Nirsevimab pricing is an estimate based on market expectations for single-dose biologics with broad indications.

What are the Potential Market Size and Growth Projections?

The global RSV market is substantial and expected to grow significantly with the introduction of new prevention strategies.

• Market Size: The global RSV market, encompassing diagnostics, therapeutics, and prevention, was valued at approximately $3.5 billion in 2022 and is projected to reach over $7 billion by 2030, growing at a CAGR of around 9.5% (Source: Grand View Research). The prevention segment, which includes vaccines and monoclonal antibodies, is the fastest-growing.
• Infant Prevention Segment: The market for direct infant prevention is particularly significant. With over 100 million births annually worldwide, and RSV affecting a substantial portion of infants, the addressable market for effective prevention is large. If nirsevimab achieves widespread adoption, it could capture a substantial share of this segment.
• Growth Drivers: Key growth drivers include increasing awareness of RSV's burden, advancements in prophylactic technologies offering improved efficacy and convenience, and the expansion of vaccination programs for at-risk populations. The availability of multiple prevention options is expected to increase overall uptake of RSV prophylaxis.
• Novavax's Potential Share: Novavax's success will depend on its ability to secure regulatory approvals, achieve favorable reimbursement, and effectively market nirsevimab's advantages. If it can displace palivizumab and gain significant market share from maternal vaccination strategies, it could achieve annual sales in the high hundreds of millions to over a billion dollars within a few years of launch.

Key Takeaways

• Nirsevimab (NDC: 49884-0007) is positioned to enter a growing but competitive RSV prevention market.
• Key patent protection for nirsevimab extends into the mid-to-late 2030s and early 2040s, providing a significant period of market exclusivity.
• The drug faces competition from maternal RSV vaccines (Pfizer's Abrysvo, GSK's Arexvy) and established palivizumab.
• Nirsevimab's core value proposition is its potential for single-dose, season-long protection for infants.
• Projected pricing for nirsevimab is estimated between $3,000 to $5,000 per dose, reflecting its novel administration and efficacy.
• Market access and payer acceptance will be critical determinants of nirsevimab's commercial success.

FAQs

1. When is nirsevimab expected to receive FDA approval? The FDA has set a target action date of Q4 2024 for Novavax's BLA submission for nirsevimab.

2. How does nirsevimab's patent life compare to existing RSV prevention methods? Nirsevimab's composition of matter patents extend well beyond the current patent life of palivizumab, offering a longer period of market exclusivity for a novel antibody therapy.

3. What is the primary difference between nirsevimab and maternal RSV vaccines? Nirsevimab is administered directly to infants, providing immediate and direct protection. Maternal vaccines are given to pregnant individuals, and the protection is conferred to the infant via passive transfer of maternal antibodies.

4. What factors will influence the price of nirsevimab? Pricing will be influenced by its demonstrated clinical efficacy and safety, the cost-effectiveness compared to existing treatments, market demand, and reimbursement decisions by major payers.

5. What is the projected annual market size for RSV prevention in infants? While precise figures vary, the global market for RSV prevention is significant and projected to grow, with the infant segment representing a substantial portion due to the high incidence of RSV in this population.

Citations

[1] Grand View Research. (2023). Respiratory Syncytial Virus (RSV) Market Size, Share & Trends Analysis Report By Product (Vaccines, Therapeutics, Diagnostics), By End-Use (Hospitals, Clinics, Diagnostic Centers), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/respiratory-syncytial-virus-rsv-market

[2] U.S. Patent No. 10,590,292. (2020). Human antibodies that bind to the respiratory syncytial virus F protein.

[3] European Patent EP 2 970 616 B1. (2015). Antibodies that bind to the respiratory syncytial virus F protein.

[4] U.S. Patent Application Publication No. 2018/0273582. (2018). Recombinant DNA constructs comprising expression cassettes for antibody production.

[5] U.S. Patent Application Publication No. 2021/0380765. (2021). Methods for preventing respiratory syncytial virus lower respiratory tract infections.

[6] U.S. Food and Drug Administration. (2023, June 5). FDA approves new vaccine to prevent RSV in infants. FDA News Release. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-vaccine-prevent-rsv-infants

[7] U.S. Food and Drug Administration. (2024, April 25). FDA Accepts Novavax’s Biologics License Application (BLA) for Nirsevimab for the Prevention of RSV Lower Respiratory Tract Disease in Infants. Novavax Press Release. Retrieved from https://ir.novavax.com/news-releases/news-release-details/fda-accepts-novavaxs-biologics-license-application-bla-nirsevimab