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Lamotrigine - Generic Drug Details

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What are the generic sources for lamotrigine and what is the scope of lamotrigine patent protection?

Lamotrigine is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Anchen Pharms, Handa Pharms Llc, Par Pharm, Torrent Pharms Ltd, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Apotex Inc, Cipla Ltd, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Wockhardt, and Zydus Pharms Usa, and is included in forty-nine NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has one hundred and ten patent family members in thirty-eight countries.

There are thirty-two drug master file entries for lamotrigine. Sixty-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for lamotrigine

International Patents:	110
US Patents:	5
Tradenames:	5
Applicants:	36
NDAs:	49
Drug Master File Entries:	32
Suppliers / Packagers:	64
Bulk Api Vendors:	95
Clinical Trials:	175
Patent Applications:	6,317
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lamotrigine
DailyMed Link:	lamotrigine at DailyMed

Pharmacology for lamotrigine

Drug Class	Anti-epileptic Agent Mood Stabilizer Calculi Dissolution Agent Anti-coagulant
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity Decreased Coagulation Factor Activity

Synonyms for lamotrigine

1,2,4-Triazine-3,5-diamine, 6-(2,3-dichlorophenyl)-

3,5-diamino-(2,3-dichlorophenyl)-1,2,4-triazine

3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine

3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine

3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine

3,5-diamino-6-(2,3,-dichlorophenyl)-1,2,4-triazine

57L841

6-(2,2,4-triazine-3,5-diyldiamine

6-(2,3-Dichloro-phenyl)-[1,2,4]triazine-3,5-diamine

6-(2,3-Dichloro-phenyl)-[1,2,4]triazine-3,5-diamine(lamotrigine)

6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine

6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diyldiamine

6-[2,3-bis(chloranyl)phenyl]-1,2,4-triazine-3,5-diamine

84057-84-1

A840709

AB0014255

AB00384359_17

AB00384359_18

AB00384359-16

AC-10298

AC1L1GWT

AJ-08354

AK-72807

AKOS005561147

AN-35947

ANW-44921

AT-15488

B2249

BC200572

BDBM50031299

BIDD:GT0794

Bio-0056

BR-72807

BW 430C

BW-430C

BW430C

C9H7Cl2N5

CAS-84057-84-1

CCG-100856

CHEBI:6367

CHEMBL741

CPD000058464

Crisomet

CS-2616

CTK8B4406

D00354

D03FLC

DB00555

Desitin Brand of Lamotrigine

DSSTox_CID_3195

DSSTox_GSID_23195

DSSTox_RID_76918

DTXSID2023195

EINECS 281-901-8

EU-0100688

EUR-1048

F2173-0540

Faes Brand of Lamotrigine

FT-0602546

GI 267119X

GI 267119X; 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine

Glaxo Wellcome Brand of Lamotrigine

GlaxoSmithKline Brand of Lamotrigine

GTPL2622

GW 273293

HE054180

HE395696

HMS2051C10

HMS2089M08

HMS2093P21

HMS2230L04

HMS3262I17

HMS3268G17

HMS3371O16

HMS3393C10

HMS3657A17

HSDB 7526

HY-B0495

hydroxymethyl progesterone

J10032

Juste Brand of Lamotrigine

K499

KS-00000XIV

KS-1074

L 3791

L0241

Labileno

Lamictal

Lamictal (TN)

Lamictal Cd

Lamictal ODT

Lamictal XR

Lamictin

Lamictin (TN)

Lamiktal

Lamitor

lamitrin

lamotrigin

Lamotrigina

Lamotrigina [Spanish]

Lamotrigine (JAN/USAN/INN)

Lamotrigine [USAN:INN:BAN]

Lamotrigine [USAN:USP:INN:BAN]

Lamotrigine 1.0 mg/ml in Methanol

Lamotrigine for peak identification, European Pharmacopoeia (EP) Reference Standard

Lamotrigine for system suitability, European Pharmacopoeia (EP) Reference Standard

Lamotrigine, >=98%, powder

Lamotrigine, European Pharmacopoeia (EP) Reference Standard

Lamotrigine, pharmaceutical secondary standard; traceable to USP and PhEur

Lamotrigine, United States Pharmacopeia (USP) Reference Standard

Lamotriginum

Lamotriginum [Latin]

Lopac-L-3791

Lopac0_000688

LP00688

LS-155249

MCULE-7648410888

MFCD00865333

MLS000069685

MLS000759486

MLS001077325

MLS001423991

MolPort-003-666-744

NC00106

NCGC00015605-01

NCGC00015605-02

NCGC00015605-03

NCGC00015605-04

NCGC00015605-05

NCGC00015605-06

NCGC00015605-07

NCGC00015605-08

NCGC00015605-09

NCGC00015605-10

NCGC00022936-02

NCGC00022936-04

NCGC00022936-05

NCGC00261373-01

NE61394

NSC-746307

NSC-759171

NSC746307

NSC759171

Opera_ID_12

Pharmakon1600-01505610

PYZRQGJRPPTADH-UHFFFAOYSA-N

Q-201221

s3024

SAM001246697

SBI-0050666.P002

SC-12025

SCHEMBL35439

SMP2_000303

SMR000058464

ST24024203

STK628377

Tocris-1611

Tox21_110179

Tox21_110179_1

Tox21_500688

TR-026049

TRI020

U3H27498KS

UNII-U3H27498KS

Z1550648755

ZINC13156

Tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
		25MG	TABLET;ORAL
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL

US Patents and Regulatory Information for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roxane	LAMOTRIGINE	lamotrigine	TABLET;ORAL	077392-003	Jan 27, 2009		DISCN	No	No
Teva	LAMOTRIGINE	lamotrigine	TABLET, CHEWABLE;ORAL	076420-002	Jun 21, 2006	AB	RX	No	No
Apotex Inc	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078625-004	Jan 27, 2009	AB	RX	No	No
Dr Reddys Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	202383-004	Jun 19, 2013	AB	RX	No	No

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Expired US Patents for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-002	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-002	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-002	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-004	Sep 8, 2000

Non-Orange Book US Patents for lamotrigine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,647,656	Orally disintegrating tablet compositions of lamotrigine

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International Patents for lamotrigine

Country	Document Number	Estimated Expiration
Argentina	040709
Japan	2005526031
Norway	20050948
Norway	334453