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Last Updated: May 26, 2020

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LAMICTAL ODT Drug Profile


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When do Lamictal Odt patents expire, and when can generic versions of Lamictal Odt launch?

Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in thirteen countries.

The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

US ANDA Litigation and Generic Entry Outlook for Lamictal Odt

A generic version of LAMICTAL ODT was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Drug patent expirations by year for LAMICTAL ODT
Drug Prices for LAMICTAL ODT

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Drug Sales Revenue Trends for LAMICTAL ODT

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Recent Clinical Trials for LAMICTAL ODT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Pharmtechnology LLCPhase 1
ClinPharmInvest, LLCPhase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all LAMICTAL ODT clinical trials

Recent Litigation for LAMICTAL ODT

Identify potential future generic entrants

District Court Litigation
Case NameDate
PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC2014-11-19

See all LAMICTAL ODT litigation

Synonyms for LAMICTAL ODT
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]tria
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
A11873
A840709
AB0014255
AB00384359_17
AB00384359_18
AB00384359-16
AC-10298
AK-72807
AKOS005561147
ANW-44921
AT-15488
B2249
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
DB-014839
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
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 XR
Lamictal,Lamotrigine
Lamiktal
Lamitor
Lamotrigina
Lamotrigina [Spanish]
lamotrigine
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
LTG;BW430C
MCULE-7648410888
MFCD00865333
MLS000069685
MLS000759486
MLS001077325
MLS001423991
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
Q410346
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
zine-3,5-diamine
Paragraph IV (Patent) Challenges for LAMICTAL ODT
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21

US Patents and Regulatory Information for LAMICTAL ODT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-002 May 8, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
AstraZeneca
Baxter
Johnson and Johnson
McKinsey

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