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LAMICTAL

NDA

LAMOTRIGINE | N020241 | GLAXOSMITHKLINE LLC

6 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2144 Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition pursuant to FDC Act Section 505(j)(2)(C) requesting that FDA declare Lamotrigine Tablets in 12.5 mg (unscored) and 75 mg (scored or unscored) strengths suitable for submission in an ANDA, with GlaxoSmithKline's LA	Suitability	2026-02-27	Open	Hyman

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lamictal (2023)

Total Spending

$111.8M

Total Claims

46,378

Beneficiaries

5,721

Avg Cost/Unit

$20.44

Spending Trend

$101.7M(2019)→$103.3M(2020)→$103.6M(2021)→$108.7M(2022)→$111.8M(2023)

YoY Change:+7.8%

5yr CAGR:+6.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain24 active DMFs9 inactive

22 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

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

38 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -68	View Letter (PDF)
May 1, 2025	SUPPL -66	View Letter (PDF)
May 1, 2025	SUPPL -67	View Letter (PDF)
Apr 1, 2021	SUPPL -64	View Letter (PDF)
Oct 14, 2020	SUPPL -58	View Letter (PDF)
Sep 11, 2020	SUPPL -61	View Letter (PDF)
Sep 1, 2020	SUPPL -62	View Letter (PDF)
Aug 19, 2020	SUPPL -6	View Letter (PDF)
Sep 26, 2019	SUPPL -60	View Letter (PDF)
Aug 15, 2019	SUPPL -59	View Letter (PDF)
Jul 24, 2018	SUPPL -56	View Letter (PDF)
Jul 6, 2018	SUPPL -57	View Letter (PDF)
May 20, 2015	SUPPL -53	View Letter (PDF)
Mar 25, 2015	SUPPL -51	View Letter (PDF)
Mar 25, 2015	SUPPL -45	View Letter (PDF)
Jan 7, 2015	SUPPL -40	View Letter (PDF)
Jan 7, 2015	SUPPL -35	View Letter (PDF)
Jun 12, 2014	SUPPL -52	View Letter (PDF)
Dec 26, 2013	SUPPL -39	View Letter (PDF)
Sep 6, 2013	SUPPL -21	View Letter (PDF)
Sep 6, 2013	SUPPL -26	View Letter (PDF)
Sep 6, 2013	SUPPL -27	View Letter (PDF)
Sep 6, 2013	SUPPL -25	View Letter (PDF)
Aug 2, 2012	SUPPL -50	View Letter (PDF)
Dec 2, 2011	SUPPL -49	View Letter (PDF)
Aug 8, 2011	SUPPL -47	View Letter (PDF)
Jun 2, 2011	SUPPL -48	View Letter (PDF)
Nov 3, 2010	SUPPL -44	View Letter (PDF)
Nov 3, 2010	SUPPL -43	View Letter (PDF)
May 13, 2009	SUPPL -36	View Letter (PDF)
May 4, 2009	SUPPL -37	View Letter (PDF)
May 4, 2009	SUPPL -38	View Letter (PDF)
Sep 27, 2006	SUPPL -10	View Letter (PDF)
Jan 22, 2004	SUPPL -16	View Letter (PDF)
Jul 6, 2003	SUPPL -17	View Letter (PDF)
Apr 18, 2003	SUPPL -18	View Letter (PDF)
Dec 14, 1998	SUPPL -3	View Letter (PDF)
Aug 24, 1998	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 100MG

RLDAB

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