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Last Updated: May 20, 2022

Lacosamide - Generic Drug Details


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

Lacosamide is the generic ingredient in two branded drugs marketed by Ucb Inc, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Indoco, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in twelve 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. Sixteen suppliers are listed for this compound. There are eight 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.

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
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
Sciegen Pharms Inc LACOSAMIDE lacosamide TABLET;ORAL 205237-001 Mar 17, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd V LACOSAMIDE lacosamide TABLET;ORAL 204787-004 Mar 17, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 RX Yes Yes 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 022253-001 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
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 022253-003 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lacosamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 C00888289/01 Switzerland See Plans and Pricing PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
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
0888289 SPC/GB09/007 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Boehringer Ingelheim
AstraZeneca
Medtronic
Johnson and Johnson

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