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LAMICTAL ODT Drug Profile
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 seventeen patent family members in twelve countries.
The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for LAMICTAL ODT
| International Patents: | 17 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 63 |
| Patent Applications: | 4,230 |
| 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 |
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-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 XR |
| Lamictin |
| Lamictin (TN) |
| Lamiktal |
| Lamitor |
| lamitrin |
| lamotrigin |
| 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, >=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 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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-003 | May 8, 2009 | AB | RX | Yes | 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 |
Paragraph IV (Patent) Challenges for LAMICTAL ODT
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Orally Disintegrating Tablets | 25 mg, 50 mg, 100 mg, and 200 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for LAMICTAL ODT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1147026 | ➤ Sign Up |
| New Zealand | 582458 | ➤ Sign Up |
| Taiwan | 200911267 | ➤ Sign Up |
| Hong Kong | 1201745 | ➤ Sign Up |
| Uruguay | 31205 | ➤ Sign Up |
| Brazil | PI0814408 | ➤ Sign Up |
| Taiwan | I547282 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
