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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 lacosamide 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. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for lacosamide

International Patents:	22
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	3
Drug Master File Entries:	22
Suppliers / Packagers:	2
Bulk Api Vendors:	75
Clinical Trials:	86
Patent Applications:	1,262
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lacosamide
DailyMed Link:	lacosamide at DailyMed

Pharmacology for lacosamide

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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

Generic filers with tentative approvals for LACOSAMIDE

Applicant	Application No.	Strength	Dosage Form
		10MG/ML	SOLUTION;ORAL
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	022253-003	Oct 28, 2008		RX	Yes	No			Y	Y
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008		RX	Yes	No
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008		RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008		RX	Yes	Yes			Y	Y

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
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010

International Patents for lacosamide

Country	Patent Number	Estimated Expiration
Australia	718577
World Intellectual Property Organization (WIPO)	9733861
World Intellectual Property Organization (WIPO)	0000463
Denmark	1038522

Supplementary Protection Certificates for lacosamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	SPC/GB09/007	United Kingdom		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	09C0006	France		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	CA 2009 00001	Denmark
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829