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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. Three 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:	3
Bulk Api Vendors:	73
Clinical Trials:	79
Patent Applications:	1,100
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)propanamide, (2R)-

481L364

563KS2PQY5

AB0020074

AB01559947-01

AB1011880

AC-22750

AC1L560M

ADD 234037

ADD 243037

ADD-234037

ADD-243037

AJ-08306

AK-80442

AKOS005146274

AM808141

AN-5196

ANW-58547

BB 0260890

BDBM50300204

CAS-175481-36-4

CHEBI:135939

CHEMBL58323

CJ-00115

CS-0529

CTK8B7781

D05OFX

D07299

DB06218

DEA No. 2746

DSSTox_CID_31455

DSSTox_GSID_57666

DSSTox_RID_97341

DTXSID1057666

EBD27785

Erlosamide

Erlosamide [INN]

Erlosamide, Vimpat, Lacosamide

ertosamide

FT-0650739

GTPL7472

harkeroside

Harkoseride

HY-13015

I01-7424

I14-32137

KS-00000XOQ

KS-1227

Lacosamide (JAN/USAN/INN)

Lacosamide (USAN/INN)

Lacosamide [USAN:INN:BAN]

Lacosamide [USAN]

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

OR059448

OR231753

PROPANAMIDE 2-(ACETYLAMINO)-3-METHOXY-N-(PHENYLMETHYL)- (2R)-

Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

RL02246

SCHEMBL35330

SPM 927

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

Tentative approvals for LACOSAMIDE

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

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
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010		RX	Yes	Yes				Y
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008		RX	Yes	No			Y	Y
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008		RX	Yes	No

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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
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	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

Non-Orange Book US Patents for lacosamide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,773,475	Anticonvulsant enantiomeric amino acid derivatives
6,048,899	Anticonvulsant enantiomeric amino acid derivatives

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International Patents for lacosamide

Country	Document Number	Estimated Expiration
Germany	69729392
Japan	3145414
European Patent Office	0888289
Canada	2248317

Supplementary Protection Certificates for lacosamide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
C001/2009	Ireland		SPC001/2009: 20091013, EXPIRES: 20220316
C0006	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
C/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