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Last Updated: May 24, 2022

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 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 022254
Tradename:VIMPAT
Applicant:Ucb Inc
Ingredient:lacosamide
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022254
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:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/20ML (10MG/ML)
Approval Date:Oct 28, 2008TE: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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008 See Plans and Pricing See Plans and Pricing
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.