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Lamotrigine - Generic Drug Details
What are the generic drug 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, 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 Ltd, 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.There are thirty-two drug master file entries for lamotrigine. Sixty-three suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for lamotrigine
| US Patents: | 5 |
| Tradenames: | 5 |
| Applicants: | 36 |
| NDAs: | 49 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 63 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 175 |
| Patent Applications: | 6,361 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | LAMOTRIGINE | lamotrigine | TABLET, CHEWABLE;ORAL | 076420-001 | Jun 21, 2006 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lupin Ltd | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078691-001 | Jun 1, 2010 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Unichem Labs Ltd | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 090170-003 | Oct 6, 2011 | 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 |
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 | ➤ 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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for lamotrigine
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009006516 | ➤ Sign Up |
| Russian Federation | 2325163 | ➤ Sign Up |
| Denmark | 1474114 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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