Lamotrigine

Treats bipolar I disorder. Sold as Lamictal, Lamictal Cd, Lamictal Xr, Lamictal Odt, Subvenite. Every FDA application for this active ingredient: 6 branded and 55 generic.

As of Nov 14, 2026, FDA lists 61 applications for Lamotrigine (sold as Lamictal, Lamictal Cd, Lamictal Xr and others), first approved Dec 27, 1994, with 17 new uses approved and 1 published complete response letter.

First approved: Dec 27, 1994
Applications: 61
New uses approved: 17
Complete response letters: 1
Medicare spending, 2025: $217M
First approved in Japan: Oct 16, 2008

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Lamotrigine	Part D	$64.0M	+8%	662,876
Lamictal	Part D	$57.5M	-4%	5,271
Lamictal XR	Part D	$47.8M	-1%	1,822
Lamotrigine ER	Part D	$36.3M	-12%	30,891
Lamotrigine ODT	Part D	$8.2M	-9%	4,711
Lamictal ODT	Part D	$2.8M	-6%	223
Lamotrigine (Orange)	Part D	$165K	-27%	220
Lamotrigine (Green)	Part D	$44K	+2%	33
Subvenite (Orange)	Part D	$37K	-25%	52
Lamotrigine (Blue)	Part D	$27K	+4%	50
Lamotrigine ODT (Orange)	Part D	$15K	-47%	44
Subvenite	Part D	$10K	-19%	168
Lamictal XR (Orange)	Part D	$9K	New	13
Subvenite (Blue)	Part D	$8K	+21%	17
Lamictal (Orange)	Part D	$6K	+3%	14
Subvenite (Green)	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LAMOTRIGINE 100 MG TABLET: $0.048 per unitGeneric · +5% in a year
LAMOTRIGINE 150 MG TABLET: $0.069 per unitGeneric · +9% in a year
LAMOTRIGINE 200 MG TABLET: $0.080 per unitGeneric · +2% in a year
LAMOTRIGINE 25 MG DISPER TAB: $0.150 per unitGeneric · -10% in a year
LAMOTRIGINE 25 MG TABLET: $0.027 per unitGeneric · -12% in a year
LAMOTRIGINE 5 MG DISPER TABLET: $0.153 per unitGeneric · -4% in a year
LAMOTRIGINE ER 100 MG TABLET: $0.667 per unitGeneric · -15% in a year
LAMOTRIGINE ER 200 MG TABLET: $0.648 per unitGeneric · -21% in a year
LAMOTRIGINE ER 25 MG TABLET: $0.361 per unitGeneric · -13% in a year
LAMOTRIGINE ER 250 MG TABLET: $1.21 per unitGeneric · +9% in a year
LAMOTRIGINE ER 300 MG TABLET: $1.28 per unitGeneric · -2% in a year
LAMOTRIGINE ER 50 MG TABLET: $0.551 per unitGeneric · -20% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaseMar 31, 2021

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of Lennox-Gastaut syndrome.Glaxo Wellcome Research and Development · designated Aug 23, 1995 · approved Aug 24, 1998

Approvals in Japan (PMDA)

First approved in Japan 166 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

LamictalDrugs with a new additional indication and a new dosage for use in the monotherapy for the treatment of typical absence seizures in patients with epilepsy. · GlaxoSmithKline K.K. · Sep 24, 2015
LamictalDrugs with a new additional indication and a new dosage for use in the monotherapy for treatment of partial seizures (including secondary generalized… · GlaxoSmithKline K.K. · Aug 29, 2014
LamictalDrugs with a new additional indication and a new dosage for the prevention of recurrence/relapse of mood episodes in patients with bipolar disorder. · GlaxoSmithKline K.K. · Jul 1, 2011
Lamictal, new ingredientDrugs containing a new active ingredient indicated for use as adjunctive treatment with other antiepileptic drugs for partial seizures (including secondary… · GlaxoSmithKline K.K. · Oct 16, 2008

Clinical Trials

11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026
Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord StimulationPersistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine, Spinal Cord Sensitivity to Neurostimulation · Brai²n	—	Recruiting	Feb 17, 2026
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineMania, Bipolar Disorder · Bristol-Myers Squibb	Phase 3	Recruiting	Aug 26, 2025
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)Bipolar Disorder Type I With Mania · Bristol-Myers Squibb	Phase 3	Recruiting	Apr 16, 2025
Lithium Versus Lamotrigine in Bipolar Disorder, Type IIBipolar II Disorder · University Hospital Bispebjerg and Frederiksberg	Phase 4	Recruiting	Dec 28, 2023
Antiepileptic Drugs in Elderly PatientsSeizure, Epileptic · Wei Zhao	—	Recruiting	Jul 15, 2022
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and BreastfeedingEpilepsy, Pregnancy Related · University of Pittsburgh	—	Recruiting	Jul 11, 2022
Precision Medicine in the Treatment of EpilepsyEpilepsy · Gitte Moos Knudsen	—	Recruiting	Jul 11, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 27, 1994	LamictalNDA 20241 · New molecular entity	Glaxosmithkline LLC	49	Marketed
Aug 24, 1998	Lamictal CdNDA 20764 · New dosage form	Glaxosmithkline LLC	42	Marketed
Jun 21, 2006	LamotrigineANDA 76420	Teva	14	Discontinued
Aug 30, 2006	LamotrigineANDA 76388	Teva	14	Discontinued
Jan 22, 2009	LamotrigineANDA 76630	Pharmobedient	3	Discontinued
Jan 22, 2009	LamotrigineANDA 78409	Chartwell Rx	3	Marketed
Jan 22, 2009	LamotrigineANDA 76701	Dr Reddys Labs Ltd	8	Marketed
Jan 22, 2009	LamotrigineANDA 76928	Watson Labs	7	Marketed
Jan 22, 2009	LamotrigineANDA 78009	Zydus Pharms USA Inc	23	Marketed
Jan 27, 2009	LamotrigineANDA 77420	Rising	12	Discontinued
Jan 27, 2009	LamotrigineANDA 77428	Natco Pharma	0	Discontinued
Jan 27, 2009	LamotrigineANDA 78525	Taro Pharm Inds	16	Marketed
Jan 27, 2009	LamotrigineANDA 78625	Rubicon Research	12	Marketed
Jan 27, 2009	LamotrigineANDA 78947	Torrent Pharms	21	Marketed
Jan 27, 2009	LamotrigineANDA 78956	Aurobindo Pharma	21	Marketed
Jan 27, 2009	LamotrigineANDA 78982	Granules	6	Discontinued
Jan 27, 2009	LamotrigineANDA 78645	Aiping Pharm Inc	5	Discontinued
Jan 27, 2009	LamotrigineANDA 76708	Dr Reddys Labs Ltd	8	Marketed
Jan 27, 2009	LamotrigineANDA 77633	Zydus Pharms USA	22	Marketed
Jan 27, 2009	LamotrigineANDA 79132	Jubilant Cadista	12	Marketed
Feb 4, 2009	LamotrigineANDA 78310	Zennova	3	Discontinued
Feb 4, 2009	LamotrigineANDA 79204	Taro	10	Discontinued
Feb 11, 2009	LamotrigineANDA 78443	Pharmobedient	2	Discontinued
Feb 19, 2009	LamotrigineANDA 79099	Glenmark Pharms Ltd	16	Marketed
May 8, 2009	Lamictal OdtNDA 22251 · New dosage form	Glaxosmithkline LLC	25	Marketed
May 29, 2009	Lamictal XrNDA 22115 · New dosage form	Glaxosmithkline LLC	26	Marketed
Nov 4, 2009	LamotrigineANDA 90401	Aurobindo Pharma	18	Marketed
Jan 29, 2010	Lamictal XrNDA 22509 · New dosage form	Smithkline Beecham	0	Marketed
Jun 1, 2010	LamotrigineANDA 78691	Lupin Ltd	10	Discontinued
Nov 1, 2010	LamotrigineANDA 77783	Chartwell Molecular	6	Discontinued
Jan 13, 2011	LamotrigineANDA 90607	Alembic Pharms Ltd	19	Marketed
Feb 28, 2011	LamotrigineANDA 200220	Jubilant Generics	7	Discontinued
Apr 8, 2011	LamotrigineANDA 78669	Actavis Totowa	0	Discontinued
Apr 19, 2011	LamotrigineANDA 78134	Hikma Pharms	9	Discontinued
Oct 6, 2011	LamotrigineANDA 90170	Unichem Labs Ltd	13	Marketed
May 4, 2012	LamotrigineANDA 90169	Glenmark Pharms Ltd	10	Marketed
Dec 26, 2012	LamotrigineANDA 201374	Ph Health	2	Marketed
Jan 4, 2013	LamotrigineANDA 202498	Sciegen Pharms	0	Marketed
Jan 18, 2013	LamotrigineANDA 201791	Ph Health	7	Discontinued
Jun 14, 2013	LamotrigineANDA 200694	Alkem Labs Ltd	3	Marketed
Jun 17, 2013	LamotrigineANDA 202887	Rubicon Research	7	Marketed
Jun 19, 2013	LamotrigineANDA 202383	Dr Reddys Labs Ltd	7	Marketed
Jul 15, 2013	LamotrigineANDA 200828	Impax Labs Inc	7	Marketed
Oct 17, 2013	LamotrigineANDA 200672	Actavis Elizabeth	6	Marketed
Dec 23, 2013	LamotrigineANDA 203370	Torrent	6	Marketed
Jun 12, 2014	LamotrigineANDA 201168	Alembic	11	Marketed
Oct 27, 2015	LamotrigineANDA 204158	Ph Health	7	Marketed
Jun 17, 2016	LamotrigineANDA 206382	Sciegen Pharms	7	Marketed
Nov 30, 2018	LamotrigineANDA 207497	Amneal Pharms	6	Marketed
Apr 1, 2020	LamotrigineANDA 207763	Zydus Pharms	4	Marketed
Jan 19, 2021	LamotrigineANDA 213271	Ajanta Pharma Ltd	2	Marketed
Dec 8, 2021	LamotrigineANDA 213949	Pharmobedient	1	Marketed
Feb 3, 2022	LamotrigineANDA 214124	J Molner	0	Marketed
Sep 26, 2024	LamotrigineANDA 204499	Ipca Labs	1	Marketed
Oct 1, 2024	LamotrigineANDA 211821	Alembic	0	Marketed
Sep 16, 2025	SubveniteNDA 218879 · New dosage form	Owp Pharms	2	Marketed
Oct 7, 2025	LamotrigineANDA 219677	Taro	1	Marketed
Jan 8, 2026	LamotrigineANDA 217100	Torrent	0	Marketed
Feb 25, 2026	LamotrigineANDA 217278	Alembic	0	Marketed
—	LamotrigineANDA 77392	Roxane	0	Discontinued
—	LamotrigineANDA 77757	Caraco	0	Discontinued

Show all 61

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jan 3, 2025	NDA 218879Product Quality, Facility Inspections	Unapproved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA