Viewing data from:

LAMICTAL CD

NDA

LAMOTRIGINE | N020764 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Actavis Elizabeth LLC - Citizen Petition FDA-2010-P-0658 · 3 docket documents Actavis Elizabeth LLC filed this citizen petition on December 29, 2010, requesting that the FDA determine that LAMICTAL (lamotrigine) Extended-Release Tablets, 300 mg, approved under NDA 22-115, were not voluntarily withdrawn for safety or efficacy reasons, citing that the product was never commerci	505(q)	2011-01-14	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

142 trials from ClinicalTrials.gov — 1 recruiting, 120 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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	—	—
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
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients NCT00223262	Phase 4	Completed	University of Texas Southwestern Medical Center	28	2002-08 → 2005-09
Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7 NCT00015106	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	1997-11 → 1999-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$11.22

per ea

Lowest NADAC/Unit

$11.22

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173052700LAMICTAL 25 MG DISPER TABLET	$11.22	EA	Brand	$0.1613	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$549.82

Highest Price

$1157.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0526-00LAMICTAL CHEWABLE DISPERSIBLE 5MG TAB	$937.50	FSS	GlaxoSmithKline	07/31/2027
00173-0526-00LAMICTAL CHEWABLE DISPERSIBLE 5MG TAB	$549.82	Big4	GlaxoSmithKline	07/31/2027
00173-0527-00LAMICTAL 25MG CHEWABLE DISPERSIBLE TAB	$1157.40	FSS	GlaxoSmithKline	07/31/2027
00173-0527-00LAMICTAL 25MG CHEWABLE DISPERSIBLE TAB	$777.87	Big4	GlaxoSmithKline	07/31/2027

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

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

36 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -61	View Letter (PDF)
May 1, 2025	SUPPL -59	View Letter (PDF)
May 1, 2025	SUPPL -60	View Letter (PDF)
Apr 1, 2021	SUPPL -57	View Letter (PDF)
Oct 14, 2020	SUPPL -51	View Letter (PDF)
Sep 11, 2020	SUPPL -54	View Letter (PDF)
Sep 1, 2020	SUPPL -55	View Letter (PDF)
Sep 26, 2019	SUPPL -53	View Letter (PDF)
Aug 15, 2019	SUPPL -52	View Letter (PDF)
Jul 24, 2018	SUPPL -49	View Letter (PDF)
Jul 6, 2018	SUPPL -50	View Letter (PDF)
May 20, 2015	SUPPL -46	View Letter (PDF)
Mar 25, 2015	SUPPL -38	View Letter (PDF)
Mar 25, 2015	SUPPL -44	View Letter (PDF)
Jan 7, 2015	SUPPL -28	View Letter (PDF)
Jan 7, 2015	SUPPL -33	View Letter (PDF)
Jun 12, 2014	SUPPL -45	View Letter (PDF)
Dec 26, 2013	SUPPL -32	View Letter (PDF)
Sep 6, 2013	SUPPL -20	View Letter (PDF)
Sep 6, 2013	SUPPL -14	View Letter (PDF)
Sep 6, 2013	SUPPL -19	View Letter (PDF)
Sep 6, 2013	SUPPL -3	View Letter (PDF)
Sep 6, 2013	SUPPL -18	View Letter (PDF)
Aug 2, 2012	SUPPL -43	View Letter (PDF)
Dec 2, 2011	SUPPL -42	View Letter (PDF)
Aug 8, 2011	SUPPL -40	View Letter (PDF)
Jun 2, 2011	SUPPL -41	View Letter (PDF)
Nov 3, 2010	SUPPL -37	View Letter (PDF)
Nov 3, 2010	SUPPL -36	View Letter (PDF)
May 13, 2009	SUPPL -29	View Letter (PDF)
May 4, 2009	SUPPL -30	View Letter (PDF)
May 4, 2009	SUPPL -31	View Letter (PDF)
Jan 22, 2004	SUPPL -9	View Letter (PDF)
Jul 6, 2003	SUPPL -11	View Letter (PDF)
Dec 14, 1998	SUPPL -1	View Letter (PDF)
Aug 24, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 24, 1998

No patent or exclusivity listings for this strength.

#002 — 25MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 24, 1998

#003 — 100MG

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 24, 1998

#004 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Sep 8, 2000