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Last Updated: June 7, 2020

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VIMPAT Drug Profile


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Which patents cover Vimpat, and what generic alternatives are available?

Vimpat is a drug marketed by Ucb Inc and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-two patent family members in eleven countries.

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

US ANDA Litigation and Generic Entry Outlook for Vimpat

Vimpat was eligible for patent challenges on October 28, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 17, 2022. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are seven tentative approvals for the generic drug (lacosamide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for VIMPAT
Drug Prices for VIMPAT

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Generic Entry Opportunity Date for VIMPAT
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for VIMPAT
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 VIMPAT

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;INTRAVENOUS 022254-001 Oct 28, 2008 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
>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 VIMPAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VIMPAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 09C0006 France   Start Trial 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 SPC001/2009 Ireland   Start Trial SPC001/2009: 20091013, EXPIRES: 20220316
0888289 SPC/GB09/007 United Kingdom   Start Trial 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 CA 2009 00001 Denmark   Start Trial
0888289 C00888289/01 Switzerland   Start Trial PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Moodys
Boehringer Ingelheim
Dow
Baxter

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