omidenepag isopropyl · Ocuvex Therap · NDA 215092
Omlonti
Earliest generic entry, as listed
16 Jul 2039
Blocked by patent: US 11666563. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 13 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11666563 | use U-3454 · sets the listed date | 16 Jul 2039 |
| US 12290511 | use U-3454 | 27 Dec 2038 |
| US 10774072 | drug substance | 10 Jun 2035 |
| US 10179127 | drug product, use U-3454 | 8 Jan 2035 |
| US 10702511 | drug product, use U-3454 | 8 Jan 2035 |
| US 10765750 | drug product | 8 Jan 2035 |
| US 11197849 | drug product, use U-3454 | 8 Jan 2035 |
| US 11793798 | drug product, use U-3454 | 8 Jan 2035 |
| US 12295946 | drug product, use U-3454 | 8 Jan 2035 |
| US 9415038 | drug product, use U-3454 | 8 Jan 2035 |
| US RE48183 | drug product, use U-3454 | 8 Jan 2035 |
| US 8648097 | drug substance, drug product | 13 Oct 2029 |
| US 8685986 | drug product | 13 Oct 2029 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 22 Sep 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 |
|---|---|---|---|
| 215092 · 001 · RLD | solution, ophthalmic | 0.002% | 16 Jul 2039 |