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Last Updated: June 23, 2024

LACOSAMIDE - Generic Drug Details


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What are the generic drug sources for lacosamide and what is the scope of freedom to operate?

Lacosamide is the generic ingredient in three branded drugs marketed by Aucta, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Zydus Pharms, Ucb Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Medley Pharms, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in thirty-seven NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lacosamide has six patent family members in four countries.

There are twenty-two drug master file entries for lacosamide. Forty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for LACOSAMIDE

See drug prices for LACOSAMIDE

Recent Clinical Trials for LACOSAMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Overseas Pharmaceuticals, Ltd.Phase 1
Beijing Capton Pharmaceutical Technology Development Co., LTDPhase 1
Wayne State UniversityPhase 4

See all LACOSAMIDE clinical trials

Generic filers with tentative approvals for LACOSAMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10MG/MLSOLUTION;ORAL
⤷  Sign Up⤷  Sign Up50MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up200MGTABLET;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 LACOSAMIDE
Paragraph IV (Patent) Challenges for LACOSAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIMPAT Injection lacosamide 10 mg/mL, 20 mL 022254 1 2016-06-30
VIMPAT Tablets lacosamide 50 mg, 100 mg, 150 mg, and 200 mg 022253 14 2012-10-29
VIMPAT Oral Solution lacosamide 10 mg/mL 022255 3 2012-10-29

US Patents and Regulatory Information for LACOSAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa LACOSAMIDE lacosamide SOLUTION;INTRAVENOUS 214677-001 May 3, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Indoco LACOSAMIDE lacosamide SOLUTION;INTRAVENOUS 214301-001 Apr 7, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc LACOSAMIDE lacosamide TABLET;ORAL 205237-002 Mar 17, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare LACOSAMIDE lacosamide TABLET;ORAL 205011-003 Jul 12, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd LACOSAMIDE lacosamide SOLUTION;ORAL 209224-001 Jan 24, 2024 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd LACOSAMIDE lacosamide SOLUTION;ORAL 214672-001 May 19, 2022 AA 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 LACOSAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 ⤷  Sign Up ⤷  Sign Up
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 ⤷  Sign Up ⤷  Sign Up
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 ⤷  Sign Up ⤷  Sign Up
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008 ⤷  Sign Up ⤷  Sign Up
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 ⤷  Sign Up ⤷  Sign Up
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LACOSAMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma SA Vimpat lacosamide EMEA/H/C/000863
Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Authorised no no no 2008-08-29
UCB Pharma S.A. Lacosamide UCB lacosamide EMEA/H/C/005243
Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.,
Authorised no no no 2019-08-26
Accord Healthcare S.L.U. Lacosamide Accord lacosamide EMEA/H/C/004443
Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.Lacosamide Accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.•         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
Authorised yes no no 2017-09-18
Extrovis EU Ltd. Lacosamide Adroiq lacosamide EMEA/H/C/006047
Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.Lacosamide Adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
Authorised yes no no 2023-05-31
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LACOSAMIDE

Country Patent Number Title Estimated Expiration
European Patent Office 3981390 COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PRÉPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF) ⤷  Sign Up
China 114173763 一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Sign Up
China 114404393 一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Sign Up
China 112043681 一种拉考沙胺药物组合物及其药物制剂 (Lacosamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Sign Up
Canada 3148705 COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2020244615 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LACOSAMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 SPC/GB09/007 United Kingdom ⤷  Sign Up PRODUCT NAME: LACOSAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE FORMS; REGISTERED: UK EU/1/08/470/001 20080829; UK EU/1/08/470/002 20080829; UK EU/1/08/470/003 20080829; UK EU/1/08/470/004 20080829; UK EU/1/08/470/005 20080829; UK EU/1/08/470/006 20080829; UK EU/1/08/470/014 20080829; UK EU/1/08/470/015 20080829; UK EU/1/08/470/016 20080829; UK EU/1/08/470/007 20080829; UK EU/1/08/470/008 20080829; UK EU/1/08/470/009 20080829; UK EU/1/08/470/010 20080829; UK EU/1/08/470/012 20080829; UK EU/1/08/470/013 20080829
0888289 C300376 Netherlands ⤷  Sign Up PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0888289 09C0006 France ⤷  Sign Up PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/470/001 DU 20080829; REGISTRATION NO/DATE AT EEC: EU/1/08/470/001 DU 20080829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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