FDA Orange Book
Is there a generic for Zusduri?
Zusduri contains mitomycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zusduri (mitomycin). The Orange Book shows its last listed patent expires July 25, 2044 and its last listed exclusivity ends June 12, 2028.
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Zusduri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravesical | 40MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 215793, held by UROGEN PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zusduri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10039832 | January 20, 2031 | Method of use | U-4256 | 215793 |
| 9950069 | January 20, 2031 | Drug product | U-4256 | 215793 |
| 9040074 | January 20, 2031 | Drug product | U-4256 | 215793 |
| 12440568 | January 20, 2031 | Method of use | U-4256 | 215793 |
| 12740940 | July 25, 2044 | Method of use | U-4605 | 215793 |
Zusduri exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | June 12, 2028 | 215793 |
Questions
Is there a generic for Zusduri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zusduri (mitomycin). The Orange Book shows its last listed patent expires July 25, 2044 and its last listed exclusivity ends June 12, 2028.
What is the generic name for Zusduri?
The active ingredient in Zusduri is mitomycin, per the FDA Orange Book.
When does the Zusduri patent expire?
The last patent listed for Zusduri in the Orange Book expires July 25, 2044. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.