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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.

Summary for VIMPAT

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	3
Suppliers / Packagers:	3
Bulk Api Vendors:	73
Clinical Trials:	47
Patent Applications:	629
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMPAT
DailyMed Link:	VIMPAT at DailyMed

Pharmacology for VIMPAT

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

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)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

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 (TN)

VPPJLAIAVCUEMN-GFCCVEGCSA-N

Z1550648754

ZINC7673

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

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Expired US Patents for VIMPAT

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

Paragraph IV (Patent) Challenges for VIMPAT

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	10 mg/mL, 20 mL		2016-06-30
	Oral Solution	10 mg/mL		2012-10-29
	Tablets	50 mg, 100 mg, 150 mg, and 200 mg		2012-10-29

Non-Orange Book US Patents for VIMPAT

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 VIMPAT

Country	Document Number	Estimated Expiration
Germany	122009000010
Austria	202079
Australia	718577
Canada	2248317

Supplementary Protection Certificates for VIMPAT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
2009 00001	Denmark
0888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
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