Xofluza Generic: When Will Generic Baloxavir Marboxil Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Xofluza Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2036 About 9.5 years away Why then?
- Has the FDA approved a generic? June 2026 1 company approved Why not on sale?
- When does the last patent end? April 2041 10 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic baloxavir marboxil is expected to be available in April 2036, about 9.5 years away, first for Xofluza oral suspension. None is for sale yet. Each product has its own month below.
Why April 2036?
It is when Xofluza’s patent 10,392,406 ends. That patent covers the active ingredient, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Xofluza’s last patent runs to April 2041, how can a generic come sooner?
The 5 patents that run past the expected month, to April 2041 (10,759,814, 11,306,106, 11,261,198, 12,064,438 and 1 more), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Generic companies have been challenging Xofluza’s patents with the FDA since October 2022. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since June 2026, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually. The FDA has already approved one company to make a generic, and how many of them launch decides how far the price falls. See the price pattern
What should I do now?
Keep taking Xofluza as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
- oral suspensionApril 2036Probable · patent expires
- tablet2036 to 2037Probable · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Xofluza by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2018 October 2018 FDA Orange Book
- Patents listed 10 last runs to April 2041 A generic is expected sooner, in April 2036. See why FDA Orange Book
- Generics FDA-approved 1 company, approved June 2026 FDA Orange Book
- Pharmacies pay $161.94 per tablet, up 6.4% in a year NADAC, October 2026
- Medicare Part D spent $3M in 2025, for 17.4K people CMS Part D Spending by Drug
- Medicaid prescriptions 23.4K in the last four reported quarters, $4M CMS Medicaid drug utilization, to Q1 2026
Xofluza’s Road to a Generic
Xofluza has had the market to itself since the FDA approved it in October 2018 (Genentech Inc). Its FDA protection (new clinical information) runs to December 2027. Its 10 listed patents run to April 2041. Generic companies have challenged its patents with the FDA since October 2022.
The first generic of Xofluza is expected in April 2036.
Why that month: patent 10,392,406, on the active ingredient, ends then. That is about 5 years before the last listed patent runs out, in April 2041.
Why a Generic Can Come Before April 2041
The last listed patent runs to April 2041; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Xofluza Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xofluza’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 10,392,406, which ends in April 2036, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,815,835 | The product’s formulation | June 2030 | Active |
| 8,927,710 | The product’s formulation | May 2031 | Active |
| 8,987,441 | The active ingredient; the product’s formulation | October 2032 | Active |
| 10,392,406 Sets the expected month of generic availability | The active ingredient | April 2036 | Active |
| 10,633,397 | A way of using it (U-3000, U-2816) | April 2036 | Active |
| 10,759,814 | The active ingredient; the product’s formulation | August 2037 | Active |
| 11,306,106 | A way of using it (U-2816, U-3000) | August 2037 | Active |
| 11,261,198 | The product’s formulation | September 2038 | Active |
| 12,064,438 | The product’s formulation | October 2039 | Active |
| 11,925,648 | The product’s formulation | April 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-187 | Three years of protection for a change backed by new clinical studies. | December 2027 | Active |
Source: FDA Orange Book, application 214410, 210854. Patent numbers open the patent on Google Patents.
Patent Challenges to Xofluza
The first patent challenge to Xofluza reached the FDA in October 2022, from one company on that first day. The FDA approved a first challenger’s generic in June 2026, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Xofluza’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 40 mg and 80 mg | October 2022 | 1 company | First challenger eligible decided July 2026 | June 2026 | Not yet | September 2038 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Baloxavir Marboxil
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Xofluza, but the FDA has already approved 1 company (step 2), and every approval starts with an application.
Generic companies have challenged Xofluza’s patents with the FDA since October 2022: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in June 2026. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic baloxavir marboxil for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Norwich Pharmaceuticals Inc | June 2026 | 40MG, 80MG | AB |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Xofluza Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Xofluza 40 mg tablet
$161.94 per tablet in October 2026, up 6.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Xofluza 40 mg tablet $161.94 per tablet
- Xofluza 80 mg tablet $161.95 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $161.94 |
| September 2026 | $161.94 |
| August 2026 | $161.95 |
| July 2026 | $161.95 |
| June 2026 | $161.95 |
| May 2026 | $161.98 |
| April 2026 | $162.03 |
| March 2026 | $162.19 |
| February 2026 | $162.44 |
| January 2026 | $163.29 |
| February 2024 | $152.27 |
| January 2024 | $152.27 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Xofluza today: $161.94 per tablet for Xofluza 40 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $161.94 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Xofluza
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Xofluza, before manufacturer rebates.
- $1.6M
- January to March 2026, the latest CMS has posted
For 9,141 people, about $168 per prescription fill - $3M
- 2025, the whole year
For 17,376 people, about $166 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,570,792 | 9,141 | $168.49 |
| 2025 | $3,018,153 | 17,376 | $166.40 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xofluza only, so no generic is counted in it. What CMS says it is used for: Baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and may shorten the recovery time by 1 to 2 days.
Medicaid Prescriptions by Quarter
23,443 prescriptions in the four quarters to Q1 2026, $4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 17,923 | $3,063,270 |
| Q4 2025 | 4,569 | $776,912 |
| Q3 2025 | 209 | $37,235 |
| Q2 2025 | 742 | $124,917 |
| Q1 2025 | 13,531 | $2,245,815 |
Source: CMS Medicaid State Drug Utilization Data, over Xofluza’s own package codes.
Xofluza Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 40MG | Tablet | Oral | October 2018 | Prescription reference product |
| 2MG/ML | For suspension | Oral | November 2020 | Prescription reference product |
| 80MG | Tablet | Oral | March 2021 | Prescription reference product |
| 30MG/PACKET | For suspension | Oral | May 2025 | Prescription reference product |
| 40MG/PACKET | For suspension | Oral | May 2025 | Prescription reference product |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Tablet | Oral | October 2018 | Discontinued reference product |
Source: FDA Orange Book, Genentech Inc. Listed for sale today by A-S Medication Solutions, Genentech, Inc. and Sportpharm LLC (FDA NDC Directory).
Xofluza NDC Codes and Packages
Each Xofluza package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 50242-0599-01 | BALOXAVIR MARBOXIL 30 mg/1 granule, for suspension | packet of 1 granule | Genentech, Inc. |
| 50242-0617-01 | BALOXAVIR MARBOXIL 40 mg/1 granule, for suspension | packet of 1 granule | Genentech, Inc. |
| 50242-0860-01 | BALOXAVIR MARBOXIL 40 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0860-01 | BALOXAVIR MARBOXIL 40 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0860-86 | BALOXAVIR MARBOXIL 40 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0860-86 | BALOXAVIR MARBOXIL 40 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0583-01 | BALOXAVIR MARBOXIL 40 mg/20mL granule, for solution | bottle of 20 mL | Genentech, Inc. |
| 50242-0583-01 | BALOXAVIR MARBOXIL 40 mg/20mL granule, for solution | bottle of 20 mL | Genentech, Inc. |
Show the other 5 Xofluza packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 50242-0877-01 | BALOXAVIR MARBOXIL 80 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0877-01 | BALOXAVIR MARBOXIL 80 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0877-86 | BALOXAVIR MARBOXIL 80 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 50242-0877-86 | BALOXAVIR MARBOXIL 80 mg/1 tablet, film coated | blister pack of 1 tablet | Genentech, Inc. |
| 85766-0058-01 | BALOXAVIR MARBOXIL 80 mg/1 tablet, film coated | blister pack of 1 tablet | Sportpharm LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xofluza’s own FDA approval (NDA 214410, NDA 210854) are listed, never a generic. Some codes belong to companies that repackage Xofluza: it is the same medicine in a different package.
What a Generic Xofluza Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xofluza as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Xofluza”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Xofluza
Is there a generic for Xofluza right now?
No. As of October 9, 2026 no generic baloxavir marboxil is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Xofluza go generic?
April 2036 is the expected month, and that is probable but not certain. It is when Xofluza’s patent 10,392,406 ends. That patent covers the active ingredient, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to April 2041; a court ruling or a settlement can bring a generic sooner.
Will generic baloxavir marboxil be the same as Xofluza?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved one company to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Xofluza?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in June 2026: Norwich Pharmaceuticals Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Xofluza patent expire?
The FDA Orange Book lists 10 patents for Xofluza; the last runs to April 2041. The one behind the expected month is patent 10,392,406, which ends in April 2036. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (April 2036) weighs all of that.
Has anyone challenged the Xofluza patents?
Yes. The first patent challenge to Xofluza reached the FDA in October 2022, from one company on that first day. The FDA approved a first challenger’s generic in June 2026, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Xofluza cost now?
Pharmacies paid about $161.94 per tablet for Xofluza 40 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected April 2036 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- NinlaroIxazomib Citrate2028 to 2029
- AemcoloRifamycinNovember 2028
- DesmodaDesmopressin AcetateFebruary 2029
- RukobiaFostemsavir TromethamineJuly 2029
- VenclextaVenetoclax2032 to 2033
- InlexzoGemcitabine HydrochlorideNovember 2038
About Xofluza
- Generic name baloxavir marboxil
- How it is taken By mouth
- Company Genentech Inc
- Patent challenges Since October 2022 (FDA)
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xofluza
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.