diclofenac epolamine · Ibsa Inst Bio · NDA 206976
Licart
Earliest generic entry, as listed
20 Feb 2035
Blocked by patent: US 11344520, US 11351133. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11344520 | use U-3393 · sets the listed date | 20 Feb 2035 |
| US 11351133 | use U-3393 · sets the listed date | 20 Feb 2035 |
Exclusivities · 1 unexpired
| NPP | new patient population | 27 Mar 2029 |
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 |
|---|---|---|---|
| 206976 · 001 · RLD | system, topical | 1.3% | 20 Feb 2035 |