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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 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-one drug master file entries for this compound. Five suppliers are listed for this compound. There are eleven tentative approvals for this compound. Additional details are available on the lacosamide profile page.

Summary for NDA: 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. 0131-2470 0131-2470-99 1 BLISTER PACK in 1 CARTON (0131-2470-99) > 1 KIT in 1 BLISTER PACK
VIMPAT
lacosamide
TABLET;ORAL 022253 NDA UCB, Inc. 0131-2477 0131-2477-35 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0131-2477-35)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 28, 2008TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 29, 2017
Regulatory Exclusivity Use:INITIATION OF VIMPAT THERAPY WITH A LOADING DOSE OF 200MG
Regulatory Exclusivity Expiration:Aug 29, 2017
Regulatory Exclusivity Use:LOWER LIMIT OF 15 MINUTES FOR THE INFUSION DURATION
Patent:RE38551Patent 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

Expired Orange Book Patents for NDA: 022253

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-001Oct 28, 20085,654,301► subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-003Oct 28, 20085,654,301► subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-004Oct 28, 20085,654,301► subscribe
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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 verifification 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.

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