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LAMICTAL XR Drug Profile
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See Plans and PricingWhich patents cover Lamictal Xr, and what generic alternatives are available?
Lamictal Xr is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-five patent family members in thirty-eight countries.
The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
US ANDA Litigation and Generic Entry Outlook for Lamictal Xr
A generic version of LAMICTAL XR was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.
Summary for LAMICTAL XR
| International Patents: | 95 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 113 |
| Clinical Trials: | 64 |
| Patent Applications: | 4,428 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LAMICTAL XR |
| Drug Sales Revenues: | Drug sales revenues for LAMICTAL XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMICTAL XR |
| DailyMed Link: | LAMICTAL XR at DailyMed |
See drug prices for LAMICTAL XR
Recent Clinical Trials for LAMICTAL XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmtechnology LLC | Phase 1 |
| ClinPharmInvest, LLC | Phase 1 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Recent Litigation for LAMICTAL XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Aurobindo Pharma USA, Inc. | 2017-12-27 |
Pharmacology for LAMICTAL XR
| Drug Class | Mood Stabilizer Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for LAMICTAL XR
| 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 |
| 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 XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LAMICTAL XR | TABLET, EXTENDED RELEASE;ORAL | lamotrigine | 022115 | 2014-02-12 |
US Patents and Regulatory Information for LAMICTAL XR
| 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 XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-001 | May 29, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-002 | May 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-005 | Apr 14, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2004012741 | Start Trial |
| Cyprus | 1109119 | Start Trial |
| Spain | 2336319 | Start Trial |
| Canada | 2475544 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
