lamotrigine · Glaxosmithkline Llc · NDA 022251
Lamictal Odt
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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
- 25 Oct 2026Generic approved · 022251-0018 Jan 2026
- 25 Oct 2026Generic approved · 022251-0017 Oct 2025
- 25 Oct 2026Generic approved · 022251-00125 Feb 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022251 · 001 · RLD | tablet, orally disintegrating, oral | 25MG | open |
| 022251 · 002 · RLD | tablet, orally disintegrating, oral | 50MG | open |
| 022251 · 003 · RLD | tablet, orally disintegrating, oral | 100MG | open |
| 022251 · 004 · RLD | tablet, orally disintegrating, oral | 200MG | open |