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Last Updated: November 17, 2019

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Lacosamide - Generic Drug Details

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What are the generic drug sources for lacosamide and what is the scope of freedom to operate?

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. Three 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
Danish Pain Research CenterPhase 2
Odense University HospitalPhase 2
Duke UniversityPhase 2

See all lacosamide clinical trials

Recent Litigation for lacosamide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd.2017-05-31
UCB, Inc. v. Hetero USA Inc.2016-06-17
UCB Inc. v. Glenmark Generics Inc. USA2013-07-10

See all lacosamide litigation

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

See all lacosamide litigation

Generic filers with tentative approvals for LACOSAMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial10MG/MLSOLUTION;ORAL
  Start Trial  Start Trial200MGTABLET;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
Synonyms for lacosamide
( )-(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 (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
Vimpat (TN)
VPPJLAIAVCUEMN-GFCCVEGCSA-N
Z1550648754
ZINC7673
Paragraph IV (Patent) Challenges for LACOSAMIDE
Tradename Dosage Ingredient NDA Submissiondate
VIMPAT SOLUTION;INTRAVENOUS lacosamide 022254 2016-06-30
VIMPAT SOLUTION;ORAL lacosamide 022255 2012-10-29
VIMPAT TABLET;ORAL lacosamide 022253 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 TABLET;ORAL 022253-001 Oct 28, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
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 022253-002 Oct 28, 2008 RX Yes No   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 Y Y   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 lacosamide

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 SOLUTION;ORAL 022255-001 Apr 20, 2010   Start Trial   Start Trial
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008   Start Trial   Start Trial
>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 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 C300376 Netherlands   Start Trial PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Dow
Express Scripts
Johnson and Johnson
McKesson

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