Viewing data from:

LAMOTRIGINE

ANDA

LAMOTRIGINE | A204158 | PH HEALTH LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LAMICTAL ODT(TE code: AB)

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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$9.65

per ea

Lowest NADAC/Unit

$1.09

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49884088299LAMOTRIGINE ODT KIT (ORANGE)	$9.65	EA	Generic	—	2026-06-17
49884048611LAMOTRIGINE ODT 100 MG TABLET	$1.99	EA	Generic	—	2026-06-17
49884048511LAMOTRIGINE ODT 50 MG TABLET	$1.62	EA	Generic	—	2026-06-17
49884048711LAMOTRIGINE ODT 200 MG TABLET	$1.39	EA	Generic	—	2026-06-17
49884048411LAMOTRIGINE ODT 25 MG TABLET	$1.09	EA	Generic	—	2026-06-17

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

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.

Products (4)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 27, 2015

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 27, 2015

#003 — 100MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 27, 2015

#004 — 200MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 27, 2015