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Generated: November 13, 2018

DrugPatentWatch Database Preview

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
Tradename:VIMPAT
Applicant:Ucb Inc
Ingredient:lacosamide
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022254
Generic Entry Date for 022254*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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

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 3, 2020
Regulatory Exclusivity Use:INCORPORATION OF THE LABELING REVISIONS PROVIDED FOR IN NDA 022253/S-039 AND NDA 022255/S-022 INTO THE LACOSAMIDE INJECTION LABELING
Patent:➤ Try a Free TrialPatent Expiration:Mar 17, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
Patent:➤ Try a Free TrialPatent Expiration:Mar 17, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE

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