loteprednol etabonate · Bausch And Lomb Inc · NDA 208219
Lotemax Sm
Earliest generic entry, as listed
23 Dec 2036
Blocked by patent: US 10596107.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10596107 | product, use U-2764 | 23 Dec 2036 |
| US 11534395 | product, use U-2764 | 26 Jan 2036 |
| US 12589069 | product, use U-2764 | 26 Jan 2036 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208219 · 001 · RLD | gel, ophthalmic | 0.38% | 23 Dec 2036 |