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Last Updated: July 19, 2024

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-four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022255
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:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Apr 20, 2010TE:AARLD: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

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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