Last updated: February 20, 2026
What is the drug identified by NDC 69292-0528?
NDC 69292-0528 corresponds to Xofluza (baloxavir marboxil), a prescription antiviral medication approved by the FDA in 2018 for treating acute uncomplicated influenza in patients aged 12 and older. It is marketed notably by Shionogi and its licensing partners, such as Roche in the U.S.
What is the market size for Xofluza?
The influenza antiviral market is highly seasonal and competitive. Key figures:
- Global influenza antiviral market was valued at approximately USD 2 billion in 2021.
- Projections suggest a CAGR of 3.5% from 2022 to 2027.
- The U.S. market constitutes 50-60% of global sales, with an estimated USD 1 billion market in 2022.
Xofluza accounts for roughly 10-15% of the antiviral influenza segment in the U.S., with sales figures approximately USD 150-200 million in 2022.
What are the competitive dynamics?
Major competitors include:
- Oseltamivir (Tamiflu): Estimated USD 600 million annual sales in the U.S.
- Zanamivir (Relenza): Significantly lower market share, primarily inhaled formulations.
- Baloxavir’s competitive edge: Single-dose oral administration and activity against resistant strains.
The drug’s positioning relies on its rapid onset of action and convenience. Its market share remains limited compared to Tamiflu but holds growth potential.
What are the key price points and reimbursement trends?
- List Price: The wholesale acquisition cost (WAC) for Xofluza was approximately USD 150 per treatment dose in the U.S. as of early 2023.
- Patient co-pay: Typically ranges USD 20-50 due to insurance coverage.
- Reimbursement: Strong under Medicare Part D and private insurers, with rapid adoption in outpatient settings.
Price strategies include discounts and patient assistance programs to expand access, particularly in the context of pandemic preparedness and emerging resistant strains.
What are projections for future pricing?
Analysts project that:
- The list price may increase modestly to USD 160-180 per dose over the next 2-3 years due to manufacturing cost adjustments and inflation.
- As competition intensifies, especially if generic versions enter the market post-expiry of orphan exclusivity (expected around 2028-2029), prices could decrease by 15-30%.
Pricing models suggest:
| Year |
Projected Average Price per Dose |
Assumptions |
| 2023 |
USD 150 |
Current pricing, no new competitors |
| 2025 |
USD 155-160 |
Slight increase, stable market share |
| 2027 |
USD 140-150 |
Possible price erosion if generics enter |
What is the regulatory outlook?
- Patent protection lasts until approximately 2028-2029.
- Opportunities for biosimilar entry could prompt price competition after patent expiry.
- Ongoing trials for expanded indications could increase market size, affecting pricing and value perception.
Summary of key factors influencing pricing:
- Competitive landscape with Tamiflu and emerging generics.
- Seasonal and epidemic-driven demand.
- Insurance reimbursement policies.
- Potential introduction of generic versions post-2028.
Key Takeaways
- NDC 69292-0528 (Xofluza) commands a premium pricing strategy with a current per-dose cost around USD 150.
- Market size in the U.S. is approximately USD 150-200 million annually, with growth driven by increased adoption and resistance management.
- Projected price increases remain modest, barring new competitors, but a decline is likely with biosimilar and generic entry after patent expiration.
- The market is driven by influenza outbreak patterns, insurance coverage, and competitive effectiveness.
- Future revenues depend heavily on patent protection, regulatory developments, and competitive pressures.
FAQs
-
When is patent expiration expected for Xofluza?
Around 2028-2029, allowing for potential biosimilar competition.
-
Are there generic versions available?
Not currently. Generics are expected following patent expiry.
-
What are the main competitors?
Tamiflu (oseltamivir), Relenza (zanamivir), and potentially newer antivirals in late-stage development.
-
How does pricing compare internationally?
Prices in Europe and Asia vary, generally lower than U.S. rates due to different reimbursement policies.
-
What factors could influence future market growth?
Pandemics, resistance patterns, expanded indications, and regulatory approvals for pediatric or prophylactic use.
References
[1] IQVIA. (2023). Global influenza antiviral market report.
[2] U.S. Food and Drug Administration. (2018). FDA approval letter for Xofluza.
[3] Shionogi. (2022). Annual financial report.
[4] EvaluatePharma. (2022). Antiviral market forecast.
[5] Centers for Disease Control and Prevention. (2022). Influenza surveillance report.
