FDA Orange Book · active-ingredient family
Lamotrigine
Lamotrigine is approved as 5 brand and 54 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SUBVENITE · NDA 218879
5
Brand (NDA)
54
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, tablet, extended release, tablet, for suspension, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUBVENITERLD | OWP PHARMS | NDA 218879 | — | Sep 16, 2025 | |
| LAMICTAL XRRLD×6 | GLAXOSMITHKLINE LLC | NDA 022115 | AB | May 29, 2009 | |
| LAMICTAL ODTRLD×4 | GLAXOSMITHKLINE LLC | NDA 022251 | AB | May 08, 2009 | |
| LAMICTAL CDRLD×4 | GLAXOSMITHKLINE LLC | NDA 020764 | AB | Sep 08, 2000 | |
| LAMICTALRLD×6 | GLAXOSMITHKLINE LLC | NDA 020241 | AB | Dec 27, 1994 |
Generic (ANDA) products (54)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LAMOTRIGINE×4 | ALEMBIC | ANDA 217278 | AB | Feb 25, 2026 | |
| LAMOTRIGINE×4 | TORRENT | ANDA 217100 | AB | Jan 08, 2026 | |
| LAMOTRIGINE×4 | TARO | ANDA 219677 | AB | Oct 07, 2025 | |
| LAMOTRIGINE×3 | ALEMBIC | ANDA 211821 | AB | Oct 01, 2024 | |
| LAMOTRIGINE×4 | IPCA LABS | ANDA 204499 | AB | Sep 26, 2024 | |
| LAMOTRIGINE×4 | AMRING PHARMS | ANDA 214124 | AB | Feb 03, 2022 | |
| LAMOTRIGINE×6 | YILING | ANDA 213949 | AB | Dec 08, 2021 | |
| LAMOTRIGINE×4 | AJANTA PHARMA LTD | ANDA 213271 | AB | Jan 19, 2021 | |
| LAMOTRIGINE×6 | ZYDUS PHARMS | ANDA 207763 | AB | Apr 01, 2020 | |
| LAMOTRIGINE×6 | AMNEAL PHARMS | ANDA 207497 | AB | Nov 30, 2018 | |
| LAMOTRIGINE×4 | SCIEGEN PHARMS | ANDA 206382 | AB | Jun 17, 2016 | |
| LAMOTRIGINE×4 | PH HEALTH | ANDA 204158 | AB | Oct 27, 2015 | |
| LAMOTRIGINE×2 | ALEMBIC | ANDA 201168 | AB | Jun 12, 2014 | |
| LAMOTRIGINE×4 | TORRENT | ANDA 203370 | AB | Dec 23, 2013 | |
| LAMOTRIGINE×6 | ACTAVIS ELIZABETH | ANDA 200672 | AB | Oct 17, 2013 | |
| LAMOTRIGINE×4 | IMPAX LABS INC | ANDA 200828 | AB | Jul 15, 2013 | |
| LAMOTRIGINE×6 | DR REDDYS LABS LTD | ANDA 202383 | AB | Jun 19, 2013 | |
| LAMOTRIGINE×4 | RUBICON RESEARCH | ANDA 202887 | — | Jun 17, 2013 | |
| LAMOTRIGINE×4 | ALKEM LABS LTD | ANDA 200694 | AB | Jun 14, 2013 | |
| LAMOTRIGINE×6 | PH HEALTH | ANDA 201791 | — | Jan 18, 2013 | |
| LAMOTRIGINE×5 | SCIEGEN PHARMS | ANDA 202498 | AB | Jan 04, 2013 | |
| LAMOTRIGINE×6 | PH HEALTH | ANDA 201374 | AB | Dec 26, 2012 | |
| LAMOTRIGINE×4 | GLENMARK PHARMS LTD | ANDA 090169 | AB | May 04, 2012 | |
| LAMOTRIGINE×4 | UNICHEM LABS LTD | ANDA 090170 | AB | Oct 06, 2011 | |
| LAMOTRIGINE×4 | HIKMA PHARMS | ANDA 078134 | — | Apr 19, 2011 | |
| LAMOTRIGINE×4 | ACTAVIS TOTOWA | ANDA 078669 | — | Apr 08, 2011 | |
| LAMOTRIGINE×2 | JUBILANT GENERICS | ANDA 200220 | — | Feb 28, 2011 | |
| LAMOTRIGINE×4 | ALEMBIC PHARMS LTD | ANDA 090607 | AB | Jan 13, 2011 | |
| LAMOTRIGINE×4 | CHARTWELL MOLECULAR | ANDA 077783 | — | Nov 01, 2010 | |
| LAMOTRIGINE×4 | LUPIN LTD | ANDA 078691 | — | Jun 01, 2010 | |
| LAMOTRIGINE×2 | AUROBINDO PHARMA | ANDA 090401 | AB | Nov 04, 2009 | |
| LAMOTRIGINE×2 | GLENMARK PHARMS LTD | ANDA 079099 | AB | Feb 19, 2009 | |
| LAMOTRIGINE×4 | PHARMOBEDIENT | ANDA 078443 | — | Feb 11, 2009 | |
| LAMOTRIGINE×2 | TARO | ANDA 079204 | — | Feb 04, 2009 | |
| LAMOTRIGINE×4 | ZENNOVA | ANDA 078310 | — | Feb 04, 2009 | |
| LAMOTRIGINE×4 | AIPING PHARM INC | ANDA 078645 | — | Jan 27, 2009 | |
| LAMOTRIGINE×4 | AUROBINDO PHARMA | ANDA 078956 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×4 | DR REDDYS LABS LTD | ANDA 076708 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×4 | GRANULES | ANDA 078982 | — | Jan 27, 2009 | |
| LAMOTRIGINE×4 | JUBILANT CADISTA | ANDA 079132 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×4 | NATCO PHARMA | ANDA 077428 | — | Jan 27, 2009 | |
| LAMOTRIGINE×4 | RISING | ANDA 077420 | — | Jan 27, 2009 | |
| LAMOTRIGINE×4 | ROXANE | ANDA 077392 | — | Jan 27, 2009 | |
| LAMOTRIGINE×4 | RUBICON RESEARCH | ANDA 078625 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×4 | TARO PHARM INDS | ANDA 078525 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×4 | TORRENT PHARMS | ANDA 078947 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×6 | ZYDUS PHARMS USA | ANDA 077633 | AB | Jan 27, 2009 | |
| LAMOTRIGINE×2 | CHARTWELL RX | ANDA 078409 | — | Jan 22, 2009 | |
| LAMOTRIGINE×2 | DR REDDYS LABS LTD | ANDA 076701 | AB | Jan 22, 2009 | |
| LAMOTRIGINE×2 | PHARMOBEDIENT | ANDA 076630 | — | Jan 22, 2009 | |
| LAMOTRIGINE×3 | WATSON LABS | ANDA 076928 | AB | Jan 22, 2009 | |
| LAMOTRIGINE×2 | ZYDUS PHARMS USA INC | ANDA 078009 | AB | Jan 22, 2009 | |
| LAMOTRIGINE×4 | TEVA | ANDA 076388 | — | Aug 30, 2006 | |
| LAMOTRIGINE×2 | TEVA | ANDA 076420 | — | Jun 21, 2006 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8637512 | Jan 07, 2029 | in 2 yr 7 mo | Product |
| 11596634 | May 29, 2040 | in 14 yr 2 mo | U-4271 |
| 11612566 | May 29, 2040 | in 14 yr 2 mo | U-4271 |
Lamotrigine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
