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 two suppliers. There is one patent protecting this drug and three Paragraph IV challenges. 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. Thirty-two 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:	1
Formulation / Manufacturing:	see details

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:	Nov 16, 2023
Regulatory Exclusivity Use:	ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:	Nov 16, 2023
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Oct 14, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

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	⤷ Try a Trial	⤷ Try a Trial
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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