nepafenac · Harrow Eye · NDA 021862
Nevanac
Earliest generic entry, as listed
31 Jan 2027
Blocked by patent: US 7834059. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7834059 | use U-1095 | 31 Jan 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
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021862-00131 Jan 2027
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021862 · 001 · RLD | suspension/drops, ophthalmic | 0.1% | 31 Jan 2027 |