mitomycin · Urogen Pharma · NDA 211728
Jelmyto
Earliest generic entry, as listed
20 Jan 2031
Blocked by patent: US 12268745, US 9040074, US 9950069.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12268745 | use U-4172 · sets the listed date | 20 Jan 2031 |
| US 9040074 | drug product · sets the listed date | 20 Jan 2031 |
| US 9950069 | drug product · sets the listed date | 20 Jan 2031 |
Exclusivities · 1 unexpired
| ODE-289 | orphan drug (7 years) | 15 Apr 2027 |
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 |
|---|---|---|---|
| 211728 · 001 · RLD | powder, pyelocalyceal | 40MG/VIAL | 20 Jan 2031 |