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Last Updated: January 20, 2020

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VIMPAT Drug Profile

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When do Vimpat patents expire, 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

  Start Trial

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

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

There have been five 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.

Drug patent expirations by year for VIMPAT
Drug Prices for VIMPAT

See drug prices for VIMPAT

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.

Recent Clinical Trials for VIMPAT

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

SponsorPhase
Duke UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 1
Boston Medical CenterPhase 1

See all VIMPAT clinical trials

Recent Litigation for VIMPAT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd.2017-05-31
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
UCB, Inc. v. Hetero USA Inc.2016-06-17

See all VIMPAT litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-06-23
Alembic Pharmaceuticals, Ltd.2016-06-22
Breckenridge Phamaceutical, Inc.2016-06-21

See all VIMPAT litigation

Synonyms for VIMPAT
( )-(2R)-2-(acetylamino)-N-benzyl-3-methoxypropanamide
(2R)-2-(Acetylamino)-N-benzyl-3-methoxypropanamide
(2R)-2-(Acetylamino)-N-benzyl-3-methoxypropanamide;Lacosamide
(2R)-2-acetamido-3-methoxy-N-(phenylmethyl)propanamide
(2R)-2-acetamido-N-benzyl-3-methoxy-propanamide
(2R)-2-acetamido-N-benzyl-3-methoxypropanamide
(2R)-2-acetylamino-N-benzyl-3-methoxypropanamide
(2R)-N-benzyl-2-acetamido-3-methoxypropanamide
(R)-2-acetamido-N-benzyl-3-methoxypropanamide
(R)-2-acetamido-N-benzyl-3-methoxypropionamide
(R)-2-Acetylamino-N-benzyl-3-methoxy-propionamide
(R)-2-Acetylamino-N-benzyl-3-methoxypropionamide
(R)-N-benzyl 2-acetamido-3-methoxypropionamide
(R)-N-benzyl 2-acetamido-3-methoxypropionamide,
(R)-N-benzyl-2-acetamido-3-methoxypropanamide
(R)-N-Benzyl-2-acetamido-3-methoxypropionamide
175481-36-4
2-(Acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-
2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide, (2R)-
481L364
563KS2PQY5
A3897
AB0020074
AB01559947-01
AB1011880
AC-22750
AC1L560M
ADD 234037
ADD 243037
ADD-234037
ADD-243037
AJ-08306
AKOS005146274
AM808141
AN-5196
ANW-58547
BB 0260890
BCP02197
BDBM50300204
CAS-175481-36-4
CHEBI:135939
CHEMBL58323
CJ-00115
CS-0529
CTK8B7781
D07299
DB06218
DEA No. 2746
DSSTox_CID_31455
DSSTox_GSID_57666
DSSTox_RID_97341
DTXSID1057666
EBD27785
Erlosamide
Erlosamide [INN]
FT-0650739
GTPL7472
harkeroside
Harkoseride
HY-13015
I01-7424
I14-32137
KS-00000XOQ
KS-1227
Lacosamide
Lacosamide (JAN/USAN/INN)
Lacosamide [USAN:INN:BAN]
Lacosamide 1.0 mg/ml in Acetonitrile
Lacosamide racemate
Lacosamide solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Lacosamide; Propanamide,2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (R)-
LS-185541
M-1600
MFCD08272557
MolPort-006-170-142
NCGC00253740-01
Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-
RL02246
SB18905
SCHEMBL35330
SPM 927
SPM 927; Erlosamide
SPM-927
SPM-929
SR-01000942286
SR-01000942286-1
ST24026403
TC-064381
Tox21_113857
UNII-563KS2PQY5
V0815
Vimpat (TN)
VPPJLAIAVCUEMN-GFCCVEGCSA-N
Z1550648754
ZINC7673
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 022253-004 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;INTRAVENOUS 022254-001 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-003 Oct 28, 2008   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 C00888289/01 Switzerland   Start Trial PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
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 C300376 Netherlands   Start Trial PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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