Details for New Drug Application (NDA): 022255

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NDA 022255 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 022255

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

Pharmacology for NDA: 022255

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 022255

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIMPAT	lacosamide	SOLUTION;ORAL	022255	NDA	UCB, Inc.	0131-5410	0131-5410-72	200 mL in 1 BOTTLE, GLASS (0131-5410-72)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Apr 20, 2010	TE:	AA	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

Expired US Patents for NDA 022255

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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