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VIMPAT Drug Profile

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:	76
Clinical Trials:	49
Patent Applications:	797
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

Drug patent expirations by year for VIMPAT

Generic Entry Opportunity Date for VIMPAT

Generic Entry Dates for VIMPAT^: See Pricing* Constraining patent/regulatory exclusivity: See Pricing NDA: 022254 Dosage: SOLUTION;INTRAVENOUS
Generic Entry Dates for VIMPAT^: See Pricing* Constraining patent/regulatory exclusivity: See Pricing NDA: 022255 Dosage: SOLUTION;ORAL
Generic Entry Dates for VIMPAT^: See Pricing* Constraining patent/regulatory exclusivity: See Pricing 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
UCB, Inc. v. Hetero USA Inc.	2016-06-17
UCB Inc. v. Accord Healthcare Inc.	2013-07-10

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

US Patents and Regulatory Information for VIMPAT

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Glossary

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008	See Pricing	See Pricing
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	See Pricing	See Pricing
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	See Pricing	See Pricing
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	See Pricing	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for VIMPAT

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Injection	10 mg/mL, 20 mL	➤ Subscribe	See Pricing
➤ Subscribe	Oral Solution	10 mg/mL	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	50 mg, 100 mg, 150 mg, and 200 mg	➤ Subscribe	See Pricing

International Patents for VIMPAT

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0000463	See Pricing
Portugal	888289	See Pricing
Australia	4846499	See Pricing
Austria	202079	See Pricing
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for VIMPAT

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