dexamethasone; tobramycin · Harrow Eye · NDA 050818
Tobradex St
Earliest generic entry, as listed
3 Aug 2028
Blocked by patent: US 7795316.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7795316 | product, use U-1082 | 3 Aug 2028 |
| US 8101582 | product, use U-1082 | 19 Dec 2027 |
| US 8450287 | product | 19 Dec 2027 |
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 |
|---|---|---|---|
| 050818 · 001 · RLD | suspension/drops, ophthalmic | 0.05%;0.3% | 3 Aug 2028 |