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LAMICTAL ODT Drug Profile
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Which patents cover Lamictal Odt, and what generic alternatives are available?
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. Fifty 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 26th, 2020.
Summary for LAMICTAL ODT
| International Patents: | 18 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 113 |
| Clinical Trials: | 64 |
| Patent Applications: | 4,423 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LAMICTAL ODT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMICTAL ODT |
| DailyMed Link: | LAMICTAL ODT at DailyMed |
See drug prices for LAMICTAL ODT
Recent Clinical Trials for LAMICTAL ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ClinPharmInvest, LLC | Phase 1 |
| Pharmtechnology LLC | Phase 1 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Recent Litigation for LAMICTAL ODT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC | 2014-11-19 |
Pharmacology for LAMICTAL ODT
| Drug Class | Mood Stabilizer Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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]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 XR |
| Lamictin |
| 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 |
| 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 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LAMICTAL ODT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 582458 | Start Trial |
| China | 101801192 | Start Trial |
| Chile | 2008001966 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
