perfluorohexyloctane · Bausch And Lomb Inc · NDA 216675
Miebo
Earliest generic entry, as listed
21 Jun 2037
Blocked by patent: US RE50060. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US RE50060 | use U-4586 · sets the listed date | 21 Jun 2037 |
| US 10682315 | use U-4586 | 29 Sep 2036 |
| US 11357738 | drug product | 29 Sep 2036 |
| US 12128010 | drug product | 29 Sep 2036 |
| US 10576154 | use U-1900 | 1 Oct 2035 |
| US 10058615 | use U-1900 | 12 Sep 2033 |
| US 10369117 | use U-1900 | 12 Sep 2033 |
| US 10449164 | use U-1900 | 12 Sep 2033 |
| US 12005033 | use U-4586 | 12 Sep 2033 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 18 May 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 |
|---|---|---|---|
| 216675 · 001 · RLD | solution/drops, ophthalmic | 1.338GM/ML | 21 Jun 2037 |