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Lamotrigine - Generic Drug Details
What are the generic sources for lamotrigine and what is the scope of 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, Amneal Pharms, Anchen Pharms, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa, and is included in fifty NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Lamotrigine has one hundred and twelve patent family members in thirty-eight countries.
There are thirty-two drug master file entries for lamotrigine. Fifty-six suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for lamotrigine
| International Patents: | 112 |
| US Patents: | 5 |
| Tradenames: | 5 |
| Applicants: | 36 |
| NDAs: | 50 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 56 |
| Bulk Api Vendors: | 110 |
| Clinical Trials: | 182 |
| Patent Applications: | 5,803 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for lamotrigine |
| Drug Sales Revenues: | Drug sales revenues for lamotrigine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lamotrigine |
| DailyMed Link: | lamotrigine at DailyMed |
Recent Clinical Trials for lamotrigine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Agios Pharmaceuticals, Inc. | Phase 1 |
| Pharmtechnology LLC | Phase 1 |
| ClinPharmInvest, LLC | Phase 1 |
Recent Litigation for lamotrigine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Aurobindo Pharma USA, Inc. | 2017-12-27 |
| PAR PHARMACEUTICAL, INC. v. GLAXOSMITHKLINE LLC | 2014-11-19 |
| Janssen Pharmaceutica N V v. Mylan Pharmaceuticals Inc. | 2005-06-07 |
Generic filers with tentative approvals for LAMOTRIGINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 200MG | TABLET;ORAL |
| Start Trial | Start Trial | 150MG | TABLET;ORAL |
| Start Trial | Start Trial | 100MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for lamotrigine
| Drug Class | Mood Stabilizer Anti-epileptic Agent 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-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 |
| Lamictal XR |
| Lamictin |
| Lamiktal |
| Lamitor |
| 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 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 LAMOTRIGINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LAMICTAL XR | TABLET, EXTENDED RELEASE;ORAL | lamotrigine | 022115 | 2014-02-12 |
| LAMICTAL ODT | TABLET, ORALLY DISINTEGRATING;ORAL | lamotrigine | 022251 | 2009-12-21 |
| LAMICTAL | TABLET;ORAL | lamotrigine | 020241 | |
| LAMICTAL CD | TABLET, CHEWABLE;ORAL | lamotrigine | 020764 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | LAMOTRIGINE | lamotrigine | TABLET, CHEWABLE;ORAL | 076701-001 | Jan 22, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Elizabeth | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 203733-001 | Nov 13, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Wockhardt Ltd | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202498-005 | Jan 4, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipla | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 077783-004 | Nov 1, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glenmark Pharms Ltd | LAMOTRIGINE | lamotrigine | TABLET, CHEWABLE;ORAL | 079099-001 | Feb 19, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 077420-003 | Jan 27, 2009 | AB | RX | No | No | 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 |
Expired US Patents for lamotrigine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-003 | Aug 24, 1998 | Start Trial | Start Trial |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-004 | Sep 8, 2000 | Start Trial | Start Trial |
| Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-001 | Aug 24, 1998 | Start Trial | Start Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-006 | Dec 27, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lamotrigine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 104161733 | Start Trial |
| Israel | 166424 | Start Trial |
| Norway | 334453 | Start Trial |
| Japan | 2005526031 | Start Trial |
| Taiwan | I286079 | Start Trial |
| Russian Federation | 2325163 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.