Details for New Drug Application (NDA): 022254

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NDA 022254 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-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

Summary for 022254

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

Pharmacology for NDA: 022254

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 022254

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254	NDA	UCB, Inc.	0131-1810	0131-1810-67	10 VIAL, GLASS in 1 CARTON (0131-1810-67) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Oct 28, 2008	TE:	AP	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 022254

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	5,654,301	⤷ Subscribe
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	RE38551	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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