Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

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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 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, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, 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 thirteen patent family members in thirty-eight countries.

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

Drug Prices for lamotrigine

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Drug Sales Revenue Trends for lamotrigine

See drug sales revenues for lamotrigine

Recent Clinical Trials for lamotrigine

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SponsorPhase
Boehringer IngelheimN/A
Charite University, Berlin, GermanyN/A
Agios Pharmaceuticals, Inc.Phase 1

See all lamotrigine clinical trials

Recent Litigation for lamotrigine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Aurobindo Pharma USA, Inc.2017-12-27
PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC2014-11-19
Janssen Pharmaceutica N V v. Mylan Pharmaceuticals Inc.2005-06-07

See all lamotrigine litigation

Generic filers with tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;ORAL

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

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
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21
LAMICTAL CD TABLET, CHEWABLE;ORAL lamotrigine 020764
LAMICTAL TABLET;ORAL lamotrigine 020241

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
Taro LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 079204-001 Feb 4, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 078409-002 Jan 22, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202383-004 Jun 19, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 200828-002 Jul 15, 2013 AB RX No No   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   Start Trial
Par Pharm LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 204158-004 Oct 27, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-006 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.