FDA Orange Book
Generic for Lamictal XR
Lamictal XR contains lamotrigine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Lamictal XR is lamotrigine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Lamictal XR and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lamictal XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Marketed (Rx) | AB | 9 | AB |
| tablet, extended release, oral | 200MG | Marketed (Rx) | AB | 9 | AB |
| tablet, extended release, oral | 250MG | Marketed (Rx) | AB | 7 | AB |
| tablet, extended release, oral | 25MG | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 300MG | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 50MG | Marketed (Rx) | AB | 8 | AB |
NDA 022115, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lamotrigine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 201374 | AB (A-rated, therapeutically equivalent) | December 26, 2012 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 202498 | AB (A-rated, therapeutically equivalent) | January 4, 2013 | 100MG, 200MG, 25MG, 300MG, 50MG |
| RUBICON RESEARCH LTD | 202887 | AB (A-rated, therapeutically equivalent) | June 17, 2013 | 100MG, 200MG |
| DR REDDYS LABORATORIES LTD | 202383 | AB (A-rated, therapeutically equivalent) | June 19, 2013 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| ACTAVIS ELIZABETH LLC | 200672 | AB (A-rated, therapeutically equivalent) | October 17, 2013 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| TORRENT PHARMACEUTICALS LTD | 203370 | AB (A-rated, therapeutically equivalent) | December 23, 2013 | 100MG, 25MG, 50MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 207497 | AB (A-rated, therapeutically equivalent) | November 30, 2018 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 207763 | AB (A-rated, therapeutically equivalent) | April 1, 2020 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| PHARMOBEDIENT CONSULTING LLC | 213949 | AB (A-rated, therapeutically equivalent) | December 8, 2021 | 100MG, 200MG, 250MG, 25MG, 300MG, 50MG |
| ALEMBIC PHARMACEUTICALS LTD | 211821 | AB (A-rated, therapeutically equivalent) | October 1, 2024 | 200MG, 250MG, 300MG |
Lamictal XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8637512 | January 7, 2029 | Drug product | None | 022115 |
Lamictal XR NDC codes
Questions
Is there a generic for Lamictal XR?
Yes. The generic name for Lamictal XR is lamotrigine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lamictal XR?
The active ingredient in Lamictal XR is lamotrigine, per the FDA Orange Book.
When does the Lamictal XR patent expire?
The last patent listed for Lamictal XR in the Orange Book expires January 7, 2029. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.