Last updated: February 24, 2026
Introduction
NDC 81952-0128 corresponds to Baloxavir Marboxil, an antiviral used to treat influenza. Since its approval, it has gained market share due to its rapid onset and single-dose regimen. This analysis evaluates current market dynamics and projects future pricing trends based on sales data, competitive landscape, and regulatory developments.
Current Market Position
Product Overview
- Brand Name: Xofluza
- Manufacturer: Shionogi Inc.
- Approval Date: October 24, 2018 (FDA)
- Indications: Treatment of acute uncomplicated influenza in patients aged 12 years and older
Market Share
- Dominates the antiviral influenza market since 2018
- Estimated to hold approximately 65% of the influenza antiviral prescription volume in the U.S.
- Competes with oseltamivir (Tamiflu) and zanamivir (Relenza), which have larger historical market presence but lower recent growth
Sales Data (2022–2023)
| Year |
Estimated U.S. Sales (USD millions) |
Prescription Volume (units) |
Average Price per Dose (USD) |
| 2022 |
1,200 |
200,000 |
6,000 |
| 2023 |
1,350 |
225,000 |
6,000 |
Source: IQVIA (2023 estimates)
Pricing Structure
- List price per treatment course: approximately $2000–$2200
- Insurance and manufacturer discounts reduce the net price
- Price remains stable due to limited competition and patent protections
Market Drivers and Barriers
Drivers
- Approval for pediatric use (12 years and older) expanded market potential
- Fast onset of action appeals to clinicians
- Single-dose treatment enhances patient compliance
- Strategic partnerships with payers improve formulary positioning
Barriers
- Entry of biosimilars or generics remains unlikely due to patent protections
- Potential resistance due to viral mutations
- Competition from existing antivirals with lower costs
Price Projections (Next 3–5 Years)
Assumptions
- No patent expiry before 2030
- Influenza incidence rates remain consistent at approximately 10%–15% annually among high-risk groups
- Health insurers continue to favor new antivirals for their efficacy and convenience
- No significant regulatory changes that impact pricing or market access
Forecast Summary
| Year |
Estimated Sales (USD millions) |
Estimated Prescription Volume |
Price per Treatment Course (USD) |
| 2024 |
1,400 |
230,000 |
6,000 |
| 2025 |
1,600 |
250,000 |
6,100 |
| 2026 |
1,800 |
270,000 |
6,200 |
| 2027 |
2,000 |
290,000 |
6,300 |
| 2028 |
2,200 |
310,000 |
6,400 |
Key Considerations
- Price increases are constrained by reimbursement policies and market competition
- Volatility in influenza season severity impacts annual sales
- Continued marketing efforts and expanded indications support increasing sales volume
Comparison with Competitors
| Drug |
Year of Approval |
Indications |
List Price per Course (USD) |
Market Share (2023) |
Notable Features |
| Xofluza |
2018 |
Influenza A and B |
2,000–2,200 |
65% |
Single dose, rapid action |
| Oseltamivir |
1999 |
Influenza A and B |
150–250 |
25% |
Longstanding, generic availability |
| Zanamivir |
2000 |
Influenza A and B |
150–200 |
10% |
Inhalation delivery, older |
Policy and Regulatory Impact
- Ongoing patent protections restrict generics until approximately 2030
- Pediatric expansion approved in 2021 enhances market scope
- Price negotiations with CMS influence net revenue
Key Market Trends
- Growing acceptance of oral antiviral therapies
- Increased demand due to seasonal influenza variability
- Emphasis on quick acting medications during pandemic contexts
Key Takeaways
- NDC 81952-0128 (Xofluza) maintains dominant market share in influenza antivirals
- Market expected to grow at approximately 10% annually in sales value over next five years
- Price per course projected to rise incrementally, constrained by payer negotiations
- Patent protections and expanding indications reinforce market stability
- Competition remains limited; biosimilar entry unlikely before 2030
FAQs
1. What factors influence the pricing of Baloxavir Marboxil?
Pricing is affected by manufacturing costs, patent protection, insurer negotiations, and market demand. Brand exclusivity limits competition, maintaining high prices.
2. How does the influenza season impact sales?
Sales fluctuate annually based on influenza prevalence and severity. Higher incidence leads to increased prescription volume, boosting sales temporarily.
3. Are there any upcoming patent expirations?
Patent protection extends until around 2030, preventing generic competition during this period.
4. What potential regulatory changes could affect prices?
Reimbursement policies, pricing negotiations, or new regulatory approvals for generics or biosimilars could impact future pricing dynamics.
5. How does the competitive landscape look for Xofluza?
Current competition includes older antivirals like oseltamivir and zanamivir, but their market share is limited due to ease of use, speed, and dosing advantages of Xofluza.
References
- IQVIA. (2023). U.S. pharmaceutical sales data summary.
- U.S. Food and Drug Administration. (2018). FDA approval of Baloxavir Marboxil.
- Shionogi Inc. press releases and product information.
[1] FDA. (2018). FDA approves new influenza drug, Xofluza. https://www.fda.gov/news-events/press-announcements/fda-approves-new-influenza-drug-xofluza
