Zusduri Generic: When Will Generic Mitomycin 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
Zusduri Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2036 to 2037 A wide window Why then?
- Has the FDA approved a generic? March 1988 6 companies approved
- When does the last patent end? January 2031 4 patents listed with the FDA
- Can you buy a generic today? Yes 14 companies list one in some form
A generic matching Zusduri is expected to be available between 2036 and 2037. A generic mitomycin is already listed for sale in some form by 14 companies, so ask your pharmacy whether one matches Zusduri.
Why 2036 to 2037?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
Will the generic cost less?
Usually. The FDA has already approved 6 companies 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?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Zusduri, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Zusduri by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- 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 2025 June 2025 FDA Orange Book
- Patents listed 4 last runs to January 2031 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved March 1988 FDA Orange Book
Zusduri’s Road to a Generic
Zusduri has had the market to itself since the FDA approved it in June 2025 (Urogen Pharma Ltd). Its FDA protection (new product) runs to June 2028. Its 4 listed patents run to January 2031.
The first generic of Zusduri is expected between 2036 and 2037.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
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.
Zusduri Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zusduri’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,040,074 | The product’s formulation; a way of using it (U-4256) | January 2031 | Active |
| 9,950,069 | The product’s formulation; a way of using it (U-4256) | January 2031 | Active |
| 10,039,832 | A way of using it (U-4256) | January 2031 | Active |
| 12,440,568 | A way of using it (U-4256) | January 2031 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | June 2028 | Active |
Source: FDA Orange Book, application 215793. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Mitomycin
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 Zusduri, but the FDA has already approved 6 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 6 companies, the first in March 1988. 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
Yes. A generic mitomycin in some form is listed for sale by 14 companies. Ask your pharmacy whether it can fill your prescription with it.
Accord BioPharma Inc., Accord Healthcare, Inc., Accord Healthcare Inc, Archis Pharma LLC, BluePoint Laboratories, Bryant Ranch Prepack and 8 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | April 1995 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Accord Healthcare Inc | April 1998 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Rk Pharma Inc | October 2017 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Gland Pharma Ltd | October 2021 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Meitheal Pharmaceuticals Inc | September 2022 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Fresenius Kabi USA LLC | April 2024 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | AP |
| Bristol Myers Co discontinued | March 1988 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | – |
| Hospira Inc discontinued | November 1995 | 20MG/VIAL | – |
| Eugia Pharma Specialities Ltd discontinued | October 2023 | 5MG/VIAL, 20MG/VIAL, 40MG/VIAL | – |
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).
Zusduri Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Zusduri, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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.
Zusduri Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 40MG/VIAL | Powder | Intravesical | June 2025 | Prescription reference product |
Source: FDA Orange Book, Urogen Pharma Ltd. Listed for sale today by UroGen Pharma, Inc (FDA NDC Directory).
Zusduri NDC Codes and Packages
Each Zusduri 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 |
|---|---|---|---|
| 72493-0106-03 | kit | 1 KIT in 1 CARTON * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE * 60 mL in 1 VIAL, SINGLE-DOSE | UroGen Pharma, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zusduri’s own FDA approval (NDA 215793) are listed, never a generic. Some codes belong to companies that repackage Zusduri: it is the same medicine in a different package.
What a Generic Zusduri Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Zusduri
Is there a generic for Zusduri right now?
Yes. The FDA NDC Directory lists a generic mitomycin in some form from 14 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Zusduri go generic?
2036 to 2037 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Will generic mitomycin be the same as Zusduri?
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 6 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Zusduri?
Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in March 1988: Hikma Pharmaceuticals USA Inc, Accord Healthcare Inc, Rk Pharma Inc, Gland Pharma Ltd and 2 more. 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 Zusduri patent expire?
The FDA Orange Book lists 4 patents for Zusduri; the last runs to January 2031. 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 window on this page (2036 to 2037) weighs all of that.
Changes to This Projection
- First generic expected 2036 to 2037 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
- XaraCollBupivacaine HydrochlorideMay 2029
- Esmolol HydrochlorideEsmolol HydrochlorideMarch 2033
- AzstarysDexmethylphenidate Hydrochloride and Serdexmethylphenidate ChlorideDecember 2037
- KomziftiZiftomenibNovember 2039
- SymbravoMeloxicam and RizatriptanMay 2040
- OsmoprepSodium Phosphate, Dibasic, Anhydrous and Sodium Phosphate, Monobasic, MonohydrateTBD no date yet
About Zusduri
- Generic name mitomycin
- How it is taken Into the bladder
- Company Urogen Pharma Ltd
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zusduri
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.