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Last Updated: June 28, 2022

LACOSAMIDE - Generic Drug Details


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What are the generic sources for lacosamide and what is the scope of patent protection?

Lacosamide is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Indoco, Ucb Inc, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in fourteen 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 twenty-two patent family members in eleven countries.

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

Recent Clinical Trials for LACOSAMIDE

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

SponsorPhase
Sherief Abd-ElsalamPhase 3
UCB Biopharma SRLPhase 2/Phase 3
University of California, Los AngelesPhase 4

See all LACOSAMIDE clinical trials

Generic filers with tentative approvals for LACOSAMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing150MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Hetero Labs Ltd V LACOSAMIDE lacosamide TABLET;ORAL 204787-002 Mar 17, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd LACOSAMIDE lacosamide TABLET;ORAL 214695-002 Mar 31, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn Labs Pvt Ltd LACOSAMIDE lacosamide TABLET;ORAL 204921-003 Mar 17, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022253-003 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for LACOSAMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 09C0006 France See Plans and Pricing 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
0888289 C300376 Netherlands See Plans and Pricing PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0888289 SPC001/2009 Ireland See Plans and Pricing SPC001/2009: 20091013, EXPIRES: 20220316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
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McKinsey
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