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Generated: December 12, 2018

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LAMOTRIGINE - Generic Drug Details

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What are the generic drug sources for lamotrigine and what is the scope of lamotrigine freedom to operate?

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, 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-one suppliers are listed for this compound. There are three tentative approvals for this compound.

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
➤ Sign Up➤ Sign Up200MGTABLET;ORAL
➤ Sign Up➤ Sign Up150MGTABLET;ORAL
➤ Sign Up➤ Sign Up100MGTABLET;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
Hikma Pharms LAMOTRIGINE lamotrigine TABLET;ORAL 078134-003 Apr 19, 2011 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Anchen Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 201374-006 Dec 26, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sciegen Pharms Inc LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 206382-003 Jun 17, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd LAMOTRIGINE lamotrigine TABLET;ORAL 078691-004 Jun 1, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
McKesson
Citi
Healthtrust
Colorcon
McKinsey
Baxter
Cipla

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