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Lamotrigine - Generic Drug Details
What are the generic sources for lamotrigine and what is the scope of lamotrigine patent protection?
Lamotrigine has one hundred and ten patent family members in thirty-eight countries.
There are thirty-two drug master file entries for lamotrigine. Fifty-seven 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: | 57 |
Bulk Api Vendors: | 91 |
Clinical Trials: | 175 |
Patent Applications: | 6,345 |
Formulation / Manufacturing: | see details |
Drug Prices: | see low prices |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Generics | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 090169-002 | May 12, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
Taro Pharm Inds | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078525-002 | Jan 27, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
Alkem Labs Ltd | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 200694-003 | Jun 14, 2013 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
Hikma Pharms | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078134-002 | Apr 19, 2011 | DISCN | 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 |
Expired US Patents for lamotrigine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-003 | Aug 24, 1998 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-001 | Aug 24, 1998 | ➤ Sign Up | ➤ Sign Up |
Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-001 | Aug 24, 1998 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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 | ➤ Sign Up |
Patent No. | Title | Estimated Patent Expiration |
International Patents for lamotrigine
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