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Last Updated: June 13, 2021

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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 one branded drug marketed by Ucb Inc and is included in three 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. Two suppliers are listed for this compound. There are seven tentative approvals for this compound.

Recent Clinical Trials for LACOSAMIDE

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

SponsorPhase
UCB Biopharma SRLPhase 3
UCB Biopharma SRLPhase 2/Phase 3
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4

See all LACOSAMIDE clinical trials

Generic filers with tentative approvals for LACOSAMIDE
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free150MGTABLET;ORAL
  Get Started Free  Get Started Free10MG/MLSOLUTION;ORAL
  Get Started Free  Get Started Free150MGTABLET;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 NDA Submissiondate
VIMPAT SOLUTION;INTRAVENOUS lacosamide 022254 2016-06-30
VIMPAT TABLET;ORAL lacosamide 022253 2012-10-29
VIMPAT SOLUTION;ORAL lacosamide 022255 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
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
>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 SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008   Get Started Free   Get Started Free
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010   Get Started Free   Get Started Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008   Get Started Free   Get Started Free
>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   Get Started Free PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
0888289 SPC001/2009 Ireland   Get Started Free SPC001/2009: 20091013, EXPIRES: 20220316
0888289 09C0006 France   Get Started Free 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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Serving leading biopharmaceutical companies globally:

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Merck
AstraZeneca
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McKinsey
Moodys

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