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Last Updated: March 18, 2024

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. Thirty-eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022253
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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 28, 2008TE:ABRLD: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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 28, 2008TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 14, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 022253

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