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Last Updated: May 6, 2021

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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. Two suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 022254
Applicant:Ucb Inc
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022254
Generic Entry Date for 022254*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Paragraph IV (Patent) Challenges for 022254
Tradename Dosage Ingredient NDA Submissiondate
VIMPAT SOLUTION;INTRAVENOUS lacosamide 022254 2016-06-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/20ML (10MG/ML)
Approval Date:Oct 28, 2008TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Mar 17, 2022Product Flag?YSubstance Flag?YDelist Request?

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