Zusduri is a drug owned by Urogen Pharma Ltd. It is protected by 3 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 | NA |
Jan, 2031
(5 years from now) | Active |
| US9950069 | Material and method for treating internal cavities |
Jan, 2031
(5 years from now) | Active |
| US9040074 | Material and method for treating internal cavities |
Jan, 2031
(5 years from now) | Active |
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
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 Pharma 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 |