dexamethasone · Ocular Therapeutix · NDA 208742
Dextenza
Earliest generic entry, as listed
26 Apr 2041
Blocked by patent: US 12144889. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
7 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12144889 | use U-1680 · sets the listed date | 26 Apr 2041 |
| US 11458041 | use U-1680, U-3455 | 16 Nov 2037 |
| US 11458041 listing row | use U-1680 | 16 Nov 2037 |
| US 11458041 listing row | use U-3455 | 16 Nov 2037 |
| US 12150896 | use U-1680, U-3455 | 7 Oct 2036 |
| US 12150896 listing row | use U-1680 | 7 Oct 2036 |
| US 12150896 listing row | use U-3455 | 7 Oct 2036 |
| US 8409606 | drug product | 14 May 2030 |
| US 8563027 | use U-2487 | 12 Feb 2030 |
Exclusivities · 1 unexpired
| NPP | new patient population | 7 Apr 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 |
|---|---|---|---|
| 208742 · 001 · RLD | insert, ophthalmic | 0.4MG | 26 Apr 2041 |