Viewing data from:

LAMICTAL ODT

NDA

LAMOTRIGINE | N022251 | GLAXOSMITHKLINE LLC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC et al 2:2014cv06627 1 patentANDA 204158lamotrigine	E.D. Pa.	2014-11-19	Terminated 2015-06-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

143 trials from ClinicalTrials.gov — 2 recruiting, 120 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)NCT06929273	Phase 3	Recruiting	Bristol-Myers Squibb	450	2025-07-18 → 2028-06-13
Ketogenic Diet for New-Onset Absence Epilepsy NCT04274179	Phase 3	Recruiting	Johns Hopkins University	40	2020-08-10 → 2028-05-01
Comparison of Oral Lamotrigine Versus Pregabalin for Control of Acute and Chronic Pain NCT03419949	—	AVAILABLE	Assiut University	—	—
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study NCT02303106	Phase 4	Completed	Per Damkier	12	2014-11 → 2015-04
Bipolar Disorder Study for Men and Women NCT00056277	Phase 3	Completed	GlaxoSmithKline	150	2003-02-27 → 2005-12-14
Lamotrigine Monotherapy in Pediatric Bipolar Disorder NCT00176228	Phase 2	Completed	University of Illinois at Chicago	48	2004-02 → 2008-01
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures NCT00292461	Phase 3	Completed	Eisai Inc.	64	2006-03 → 2009-09
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy NCT00807989	Phase 4	Completed	Yonsei University	207	2008-03 → 2012-05
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition NCT01131975	Phase 1	Completed	Dr. Reddy's Laboratories Limited	26	2003-01 → 2003-03
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer NCT00068445	Phase 3	Completed	Alliance for Clinical Trials in Oncology	131	2004-02 → 2013-11

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$17.49

per ea

Lowest NADAC/Unit

$12.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173077702LAMICTAL ODT 200 MG TABLET	$17.49	EA	Brand	$1.47	2026-08-19
00173077602LAMICTAL ODT 100 MG TABLET	$14.65	EA	Brand	$1.80	2026-08-19
00173077402LAMICTAL ODT 50 MG TABLET	$13.65	EA	Brand	$1.28	2026-05-20
00173077202LAMICTAL ODT 25 MG TABLET	$12.82	EA	Brand	$1.27	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$294.51

Highest Price

$1285.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0772-02LAMICTAL ODT TABLETS 25MG MAINT 30S	$294.51	Big4	GlaxoSmithKline	07/31/2027
00173-0772-02LAMICTAL ODT TABLETS 25MG MAINT 30S	$385.60	FSS	GlaxoSmithKline	07/31/2027
00173-0774-02LAMICTAL ODT TABLETS 50MG MAINT 30S	$315.79	Big4	GlaxoSmithKline	07/31/2027
00173-0774-02LAMICTAL ODT TABLETS 50MG MAINT 30S	$413.04	FSS	GlaxoSmithKline	07/31/2027
00173-0776-02LAMICTAL ODT TABLETS 100MG MAINT 30S	$337.78	Big4	GlaxoSmithKline	07/31/2027
00173-0776-02LAMICTAL ODT TABLETS 100MG MAINT 30S	$440.40	FSS	GlaxoSmithKline	07/31/2027

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Lamictal ODT (2024)

Total Spending

$3.0M

Total Claims

1,808

Beneficiaries

241

Avg Cost/Unit

$15.99

Spending Trend

$3.4M(2019)→$3.6M(2020)→$3.7M(2021)→$4.0M(2022)→$3.5M(2023)→$3.0M(2024)

YoY Change:-6.5%

5yr CAGR:+4.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain25 active DMFs9 inactive

23 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVLAMOTRIGINE

DMF 159242002

JUBILANT BIOSYS LTDLAMOTRIGINE USP

DMF 161422002

COHANCE LIFESCIENCES LTDLAMOTRIGINE USP

DMF 162592002

DR REDDYS LABORATORIES LTDLAMOTRIGINE

DMF 164802003

MEDICHEM SALAMOTRIGINE

DMF 172312004

MATRIX PHARMACORP PRIVATE LTDLAMOTRIGINE USP

DMF 177402004

ZYDUS LIFESCIENCES LTDLAMOTRIGINE USP

DMF 180902005

CIPLA LTDLAMOTRIGINE USP

DMF 184212005

ALEMBIC PHARMACEUTICALS LTDLAMOTRIGINE USP

DMF 187322005

TARO PHARMACEUTICAL INDUSTRIES LTDLAMOTRIGINE USP

DMF 189602005

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDLAMOTRIGINE, USP

DMF 195412006

LUPIN LTDLAMOTRIGINE USP (MICRONISED)

DMF 198922006

APITORIA PHARMA PRIVATE LTDLAMOTRIGINE USP (NON-STERILE DRUG SUBSTANCE)

DMF 199082006

TORRENT PHARMACEUTICALS LTDLAMOTRIGINE USP

DMF 202892007

ZAKLADY FARMACEUTYCZNE POLPHARMA SALAMOTRIGINE

DMF 205482007

UNICHEM LABORATORIES LTDLAMOTRIGINE USP API

DMF 208352007

UNIMARK REMEDIES LTDLAMOTRIGINE USP

DMF 228132009

COHANCE LIFESCIENCES LTDLAMOTRIGINE USP

DMF 232512009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLAMOTRIGINE USP

DMF 232622009

SYNTHEXIM CALAIRE CHIMIELAMOTRIGINE DRUG SUBSTANCE

DMF 237402010

CTX LIFE SCIENCES PVT LTDLAMOTRIGINE USP

DMF 249582011

IOL CHEMICALS AND PHARMACEUTICALS LTDLAMOTRIGINE

DMF 266272012

SYN-TECH CHEM AND PHARM CO LTDLAMOTRIGINE USP

DMF 302702016

SMS PHARMACEUTICALS LTDLAMOTRIGINE USP

DMF 342902019

IOL CHEMICALS AND PHARMACEUTICALS LTDLAMOTRIGINE USP

DMF 365312021

CF PHARMA LTDInactiveLAMOTRIGINE

DMF 181372005

GEDEON RICHTER LTDInactiveLAMOTRIGINE

DMF 183532005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLAMOTRIGINE USP

DMF 183562005

UNION QUIMICO FARMACEUTICA SA (UQUIFA)InactiveLAMOTRIGINE

DMF 184392005

APOTEX PHARMACHEM INDIA PVT LTDInactiveLAMOTRIGINE

DMF 201292007

CAMBREX PROFARMACO MILANO SRLInactiveLamotrigine

DMF 211052007

ALKEM LABORATORIES LTDInactiveLAMOTRIGINE

DMF 213902008

SEQUEL PHARMACHEM PRIVATE LTDInactiveLAMOTRIGINE EP

DMF 226562009

WATERSTONE PHARMACEUTICALS HUBEI TIANMEN CO LTDInactiveLAMOTRIGINE

DMF 257752011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -33	View Letter (PDF)
Oct 15, 2025	SUPPL -32	View Letter (PDF)
May 1, 2025	SUPPL -30	View Letter (PDF)
May 1, 2025	SUPPL -31	View Letter (PDF)
Apr 1, 2021	SUPPL -28	View Letter (PDF)
Oct 14, 2020	SUPPL -22	View Letter (PDF)
Sep 11, 2020	SUPPL -25	View Letter (PDF)
Sep 1, 2020	SUPPL -26	View Letter (PDF)
Sep 26, 2019	SUPPL -24	View Letter (PDF)
Aug 15, 2019	SUPPL -23	View Letter (PDF)
Jul 24, 2018	SUPPL -20	View Letter (PDF)
Jul 6, 2018	SUPPL -21	View Letter (PDF)
May 20, 2015	SUPPL -17	View Letter (PDF)
Mar 25, 2015	SUPPL -7	View Letter (PDF)
Mar 25, 2015	SUPPL -14	View Letter (PDF)
Jan 7, 2015	SUPPL -2	View Letter (PDF)
Jan 7, 2015	SUPPL -9	View Letter (PDF)
Jun 12, 2014	SUPPL -16	View Letter (PDF)
Dec 26, 2013	SUPPL -1	View Letter (PDF)
Aug 2, 2012	SUPPL -13	View Letter (PDF)
Dec 2, 2011	SUPPL -12	View Letter (PDF)
Aug 8, 2011	SUPPL -10	View Letter (PDF)
Jun 2, 2011	SUPPL -11	View Letter (PDF)
Nov 3, 2010	SUPPL -5	View Letter (PDF)
Nov 3, 2010	SUPPL -6	View Letter (PDF)
May 13, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 8, 2009

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 8, 2009

#003 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 8, 2009

#004 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 8, 2009