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Last Updated: May 24, 2022

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 three 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. Sixteen 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:1
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: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:Oct 14, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:See Plans and PricingPatent Expiration:Mar 17, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Expired US Patents for NDA 022253

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-003 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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