Details for New Drug Application (NDA): 022253

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NDA 022253 describes VIMPAT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the VIMPAT profile page.

The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 022253

Tradename:	VIMPAT
Applicant:	Ucb Inc
Ingredient:	lacosamide
Patents:	0

Pharmacology for NDA: 022253

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 022253

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIMPAT	lacosamide	TABLET;ORAL	022253	NDA	UCB, Inc.	0131-2477	0131-2477-35	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0131-2477-35)
VIMPAT	lacosamide	TABLET;ORAL	022253	NDA	UCB, Inc.	0131-2477	0131-2477-60	6 BLISTER PACK in 1 CARTON (0131-2477-60) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Oct 28, 2008	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 14, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Apr 28, 2026
Regulatory Exclusivity Use:	USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 28, 2008	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 14, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 022253

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	⤷ Sign Up	⤷ Sign Up
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008	⤷ Sign Up	⤷ Sign Up
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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