mitomycin · Urogen Pharma · NDA 215793
Zusduri
Earliest generic entry, as listed
25 Jul 2044
Blocked by patent: US 12740940. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12740940 | use U-4605 · sets the listed date | 25 Jul 2044 |
| US 10039832 | use U-4256 | 20 Jan 2031 |
| US 12440568 | use U-4256 | 20 Jan 2031 |
| US 9040074 | drug product, use U-4256 | 20 Jan 2031 |
| US 9950069 | drug product, use U-4256 | 20 Jan 2031 |
Exclusivities · 1 unexpired
| NP | new product | 12 Jun 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215793 · 001 · RLD | powder, intravesical | 40MG/VIAL | 25 Jul 2044 |