Prescription medicine
Baloxavir marboxil Brand names: Xofluza
Baloxavir marboxil (Xofluza) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $161.94 per Xofluza 40 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the baloxavir marboxil FDA label on DailyMed (effective December 15, 2025, Genentech, Inc.); the NDA 210854 record on Drugs@FDA; every baloxavir marboxil label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
Forms and strengths
- 30 mg
- 40 mg
- 80 mg
- 40 mg/20ml
Film-coated tablet; granule for suspension; granule for solution.
On the market
- Earliest approval on file
- October 24, 2018 Xofluza, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 17, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 9, 2039 Xofluza tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $161.94 per tablet Xofluza 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,301 through July 30, 2026
What is baloxavir marboxil used for?
From the label: indications and usageXOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. ( 1.1 ) Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. ( 1.2 ) Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. […]
Conditions named in the indications of baloxavir marboxil's FDA labels, with every medicine labeled for each:
From other baloxavir marboxil labelsInfluenza: Treatment of Influenza XOFLUZA is indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing …
FDA pharmacologic class: Polymerase Acidic Endonuclease Inhibitor.
Source: FDA drug label (Xofluza), Genentech, Inc., effective December 15, 2025 (SPL set e49e1a61-1b7c-4be5-ac84-af6240b511e7), via openFDA; the full label on DailyMed
Is there a generic for baloxavir marboxil (Xofluza)?
The FDA approved the first generic baloxavir marboxil on June 17, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 9 patents for Xofluza tablets: the compound patent runs to August 9, 2037, and the last listed entry to October 9, 2039; a patent listed only for Xofluza for oral suspension runs to April 21, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2026 first generic approved
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for baloxavir marboxil (Xofluza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $161.94 per Xofluza 40 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Xofluza 40 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Xofluza 40 mg tablet | Brand | $161.94 per tablet | $4,858.16 | -0.2% |
| Xofluza 80 mg tablet | Brand | $161.95 per tablet | $4,858.41 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for baloxavir marboxil?
The FDA Adverse Event Reporting System holds 2,301 reports that list baloxavir marboxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 136 are coded as a death and 449 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as baloxavir marboxil?
3 other medicines are given the same way (oral) and in the same FDA class as baloxavir marboxil or labeled mainly for the same use (influenza), the same class first. Influenza lists all 5 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oseltamivir | Influenza | 36 labelers | $0.150 per mL 6 mg/mL suspension | No current entry |
| Amantadine | Influenza | 34 labelers | $0.143 per capsule 100 mg capsule | No current entry |
| Rimantadine | Influenza | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as baloxavir marboxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to baloxavir marboxil
- 3 medicines for the same use
- Baloxavir marboxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other