lacosamide · Aucta · NDA 216185
Motpoly Xr
Earliest generic entry, as listed · earliest of 3 marketed strengths
5 Jun 2040
Blocked by patent: US 11337943, US 11883374, US 12042474.
Listed patents · 3 unexpired
6 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11337943 | drug product, use U-3660, U-3954 | 5 Jun 2040 |
| US 11337943 listing row | drug product, use U-3660 · sets the listed date | 5 Jun 2040 |
| US 11337943 listing row | drug product, use U-3954 · sets the listed date | 5 Jun 2040 |
| US 11883374 | drug product, use U-3660, U-3954 | 5 Jun 2040 |
| US 11883374 listing row | drug product, use U-3660 · sets the listed date | 5 Jun 2040 |
| US 11883374 listing row | drug product, use U-3954 · sets the listed date | 5 Jun 2040 |
| US 12042474 | drug product, use U-3660, U-3954 | 5 Jun 2040 |
| US 12042474 listing row | drug product, use U-3660 · sets the listed date | 5 Jun 2040 |
| US 12042474 listing row | drug product, use U-3954 · sets the listed date | 5 Jun 2040 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216185 · 001 · RLD | capsule, extended release, oral | 100MG | 5 Jun 2040 |
| 216185 · 002 · RLD | capsule, extended release, oral | 150MG | 5 Jun 2040 |
| 216185 · 003 · RLD | capsule, extended release, oral | 200MG | 5 Jun 2040 |