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Last Updated: June 23, 2024

LACOSAMIDE Drug Patent Profile


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When do Lacosamide patents expire, and when can generic versions of Lacosamide launch?

Lacosamide is a drug marketed by Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Zydus Pharms, 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-three NDAs.

The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lacosamide

A generic version of LACOSAMIDE was approved as lacosamide by ALEMBIC on March 17th, 2022.

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Drug patent expirations by year for LACOSAMIDE
Drug Prices for LACOSAMIDE

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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

Pharmacology for LACOSAMIDE
Anatomical Therapeutic Chemical (ATC) Classes 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
Sun Pharm LACOSAMIDE lacosamide TABLET;ORAL 205031-002 Mar 17, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex LACOSAMIDE lacosamide TABLET;ORAL 214567-003 Sep 23, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd LACOSAMIDE lacosamide TABLET;ORAL 214695-002 Mar 31, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd LACOSAMIDE lacosamide TABLET;ORAL 205006-003 Mar 17, 2022 AB 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

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

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