lamotrigine · Owp Pharms · NDA 218879
Subvenite
Earliest generic entry, as listed
29 May 2040
Blocked by patent: US 11596634, US 11612566, US 12629377, US 12636289.
Listed patents · 4 unexpired
10 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11596634 | use U-4271, U-4272, U-4273 | 29 May 2040 |
| US 11596634 listing row | use U-4271 · sets the listed date | 29 May 2040 |
| US 11596634 listing row | use U-4272 · sets the listed date | 29 May 2040 |
| US 11596634 listing row | use U-4273 · sets the listed date | 29 May 2040 |
| US 11612566 | use U-4271, U-4272, U-4273 | 29 May 2040 |
| US 11612566 listing row | use U-4271 · sets the listed date | 29 May 2040 |
| US 11612566 listing row | use U-4272 · sets the listed date | 29 May 2040 |
| US 11612566 listing row | use U-4273 · sets the listed date | 29 May 2040 |
| US 12629377 | drug product, use U-4539, U-4540, U-4541 | 29 May 2040 |
| US 12629377 listing row | drug product, use U-4539 · sets the listed date | 29 May 2040 |
| US 12629377 listing row | drug product, use U-4540 · sets the listed date | 29 May 2040 |
| US 12629377 listing row | drug product, use U-4541 · sets the listed date | 29 May 2040 |
| US 12636289 | drug product · sets the listed date | 29 May 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218879 · 001 · RLD | suspension, oral | 10MG/ML | 29 May 2040 |