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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

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 17^th, 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.

Summary for VIMPAT

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	3
Suppliers / Packagers:	3
Bulk Api Vendors:	76
Clinical Trials:	49
Patent Applications:	822
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIMPAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMPAT
DailyMed Link:	VIMPAT at DailyMed

See drug prices for VIMPAT

Generic Entry Opportunity Date for VIMPAT

NDA:

022254

Dosage:

SOLUTION;INTRAVENOUS

NDA:

022255

Dosage:

SOLUTION;ORAL

NDA:

022253

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

Sponsor	Phase
Duke University	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 1
Boston Medical Center	Phase 1

See all VIMPAT clinical trials

Recent Litigation for VIMPAT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Petitioner	Date
Mylan Pharmaceuticals Inc.	2016-06-23
Alembic Pharmaceuticals, Ltd.	2016-06-22
Breckenridge Phamaceutical, Inc.	2016-06-21

See all VIMPAT litigation

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)-, (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			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	Y
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008		RX	Yes	No

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
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008
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	022253-003	Oct 28, 2008

International Patents for VIMPAT

Country	Patent Number	Estimated Expiration
Germany	69705210
Netherlands	300376
Spain	2157567
World Intellectual Property Organization (WIPO)	0000463
Germany	122009000010

Supplementary Protection Certificates for VIMPAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC001/2009	Ireland		SPC001/2009: 20091013, EXPIRES: 20220316
0888289	C00888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
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	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829