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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, Amneal Pharms, Anchen Pharms, Handa Pharms Llc, Par Pharm, Torrent, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Apotex Inc, Cipla, 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 fifty 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 eleven patent family members in thirty-eight countries.

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

Summary for lamotrigine

International Patents:	111
US Patents:	5
Tradenames:	5
Applicants:	37
NDAs:	50
Drug Master File Entries:	32
Suppliers / Packagers:	62
Bulk Api Vendors:	102
Clinical Trials:	181
Patent Applications:	5,717
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lamotrigine
Drug Sales Revenues:	Drug sales revenues for lamotrigine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lamotrigine
DailyMed Link:	lamotrigine at DailyMed

Pharmacology for lamotrigine

Drug Class	Mood Stabilizer Anti-epileptic Agent 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-diamine.

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

AKOS005561147

AN-35947

ANW-44921

AT-15488

B2249

BC200572

BCP12156

BDBM50031299

BIDD:GT0794

BR-72807

BRD-K93460210-071-01-6

BW 430C

BW-430C

BW430C

C9H7Cl2N5

CAS-84057-84-1

CCG-100856

CHEBI:6367

CHEMBL741

CPD000058464

CS-2616

CTK8B4406

D00354

DB00555

DSSTox_CID_3195

DSSTox_GSID_23195

DSSTox_RID_76918

DTXSID2023195

EINECS 281-901-8

EU-0100688

EUR-1048

F2173-0540

FT-0602546

GI 267119X

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

GTPL2622

GW 273293

HMS2051C10

HMS2089M08

HMS2093P21

HMS2230L04

HMS3262I17

HMS3268G17

HMS3371O16

HMS3393C10

HMS3657A17

HMS3715H21

HSDB 7526

HY-B0495

hydroxymethyl progesterone

J10032

K499

KS-00000XIV

KS-1074

L 3791

L-205

L0241

Labileno

Lamictal

Lamictal (TN)

Lamictal Cd

Lamictal ODT

Lamictal XR

Lamictin

Lamiktal

Lamitor

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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Lamotrigine, >=98%, powder

Lamotrigine, 98%

Lamotrigine, British Pharmacopoeia (BP) Reference Standard

Lamotrigine, European Pharmacopoeia (EP) Reference Standard

Lamotrigine, Pharmaceutical Secondary Standard; Certified Reference Material

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

SR-01000000187

SR-01000000187-10

SR-01000000187-2

SR-01000000187-4

SR-01000000187-7

ST24024203

STK628377

SW197486-3

Tocris-1611

Tox21_110179

Tox21_110179_1

Tox21_500688

TR-026049

TRI020

U3H27498KS

UNII-U3H27498KS

Z1550648755

ZINC13156

Generic filers with tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Zydus Pharms Usa Inc	LAMOTRIGINE	lamotrigine	TABLET, CHEWABLE;ORAL	078009-003	Jan 22, 2009	AB	RX	No	No
Teva	LAMOTRIGINE	lamotrigine	TABLET;ORAL	076388-002	Aug 30, 2006	AB	RX	No	No
Sandoz	LAMOTRIGINE	lamotrigine	TABLET, CHEWABLE;ORAL	078409-003	Jan 22, 2009		DISCN	No	No
Zydus Pharms Usa Inc	LAMOTRIGINE	lamotrigine	TABLET, CHEWABLE;ORAL	078009-002	Jan 22, 2009	AB	RX	No	No
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-003	Aug 24, 1998		DISCN	No	No
Teva	LAMOTRIGINE	lamotrigine	TABLET, CHEWABLE;ORAL	076420-001	Jun 21, 2006	AB	RX	No	No

Expired US Patents for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-003	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-001	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-004	Sep 8, 2000
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-002	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-004	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-002	Aug 24, 1998

International Patents for lamotrigine

Country	Patent Number	Estimated Expiration
Canada	2493301
Taiwan	200911267
Brazil	0313148
Brazil	PI0814408
World Intellectual Property Organization (WIPO)	2009006516
Taiwan	200307567