Zusduri is a drug owned by Urogen Pharma Ltd. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 20, 2031. Details of Zusduri's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10039832 | Material And Method For Treating Internal Cavities |
Jan, 2031
(4 years from now) | Active |
| US9950069 | Material and method for treating internal cavities |
Jan, 2031
(4 years from now) | Active |
| US9040074 | Material and method for treating internal cavities |
Jan, 2031
(4 years from now) | Active |
| US12440568 | Material And Method For Treating Internal Cavities |
Jan, 2031
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Zusduri's patents.
Latest Legal Activities on Zusduri's Patents
Given below is the list of recent legal activities going on the following patents of Zusduri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 29 Jan, 2026 | US10039832 |
| Email Notification | 29 Oct, 2025 | US12440568 |
| Mail Miscellaneous Communication to Applicant | 29 Oct, 2025 | US12440568 |
| Miscellaneous Communication to Applicant - No Action Count | 28 Oct, 2025 | US12440568 |
| Recordation of Patent Grant Mailed | 21 Oct, 2025 | US12440568 |
| Email Notification | 14 Oct, 2025 | US12440568 |
| Mail Patent eGrant Notification | 14 Oct, 2025 | US12440568 |
| Patent eGrant Notification | 14 Oct, 2025 | US12440568 |
| Patent Issue Date Used in PTA Calculation | 14 Oct, 2025 | US12440568 |
| Recordation of Patent eGrant | 14 Oct, 2025 | US12440568 |
FDA has granted several exclusivities to Zusduri. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Zusduri, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Zusduri.
Exclusivity Information
Zusduri holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Zusduri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 12, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Zusduri is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Zusduri's family patents as well as insights into
ongoing legal events
on those patents.
Zusduri's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Zusduri:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Zusduri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zusduri Generic API suppliers:
Mitomycin is the generic name for the brand Zusduri. 9 different companies have already filed for the generic of Zusduri, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zusduri's generic
Alternative Brands for Zusduri
There are several other brand drugs using the same active ingredient (Mitomycin) as Zusduri. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mitomycin, Zusduri's active ingredient. Check the complete list of approved generic manufacturers for Zusduri
About Zusduri
Zusduri is a drug owned by Urogen Pharma Ltd. Zusduri uses Mitomycin as an active ingredient. Zusduri was launched by Urogen in 2025.
Approval Date:
Zusduri was approved by FDA for market use on 12 June, 2025.
Active Ingredient:
Zusduri uses Mitomycin as the active ingredient. Check out other Drugs and Companies using Mitomycin ingredient
Dosage:
Zusduri is available in powder form for intravesical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/VIAL | POWDER | Prescription | INTRAVESICAL |