lamotrigine · Glaxosmithkline Llc · NDA 022115
Lamictal Xr
Earliest generic entry, as listed · earliest of 6 marketed strengths
7 Jan 2029
Blocked by patent: US 8637512.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8637512 | drug product · sets the listed date | 7 Jan 2029 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022115 · 001 · RLD | tablet, extended release, oral | 25MG | 7 Jan 2029 |
| 022115 · 002 · RLD | tablet, extended release, oral | 50MG | 7 Jan 2029 |
| 022115 · 003 · RLD | tablet, extended release, oral | 100MG | 7 Jan 2029 |
| 022115 · 004 · RLD | tablet, extended release, oral | 200MG | 7 Jan 2029 |
| 022115 · 005 · RLD | tablet, extended release, oral | 300MG | 7 Jan 2029 |
| 022115 · 006 · RLD | tablet, extended release, oral | 250MG | 7 Jan 2029 |