lamotrigine hemifumarate · Azurity · NDA 221109
Lamlique
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Feb 2045
Blocked by patent: US 12605388.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12605388 | drug product · sets the listed date | 14 Feb 2045 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 221109 · 001 · RLD | suspension, oral | EQ 5MG BASE/ML | 14 Feb 2045 |
| 221109 · 002 · RLD | suspension, oral | EQ 25MG BASE/ML | 14 Feb 2045 |