budesonide · Salix · NDA 203634, 205613
Uceris
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Sep 2031
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 10307375, US 10660858, US 8895064, US 9132093, US 9192581.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10307375 | product | 7 Sep 2031 |
| US 10660858 | product | 7 Sep 2031 |
| US 8895064 | product | 7 Sep 2031 |
| US 9132093 | product | 7 Sep 2031 |
| US 9192581 | product, use U-1325 | 7 Sep 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203634 · 001 · RLD | tablet, extended release, oral | 9MG | 7 Sep 2031 |
| 205613 · 001 · RLD | aerosol, foam, rectal | 2MG/ACTUATION | open |