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Novartis
Cipla
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Chinese Patent Office
US Department of Justice
Colorcon
Covington
Dow
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Fuji

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022416

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NDA 022416 describes APTIOM, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the APTIOM profile page.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 022416
Tradename:APTIOM
Applicant:Sunovion Pharms Inc
Ingredient:eslicarbazepine acetate
Patents:7
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022416
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTIOM eslicarbazepine acetate TABLET;ORAL 022416 NDA Sunovion Pharmaceuticals Inc. 63402-202 N 63402-202-28
APTIOM eslicarbazepine acetate TABLET;ORAL 022416 NDA Sunovion Pharmaceuticals Inc. 63402-202 N 63402-202-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 8, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2018
Regulatory Exclusivity Use:1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE
Regulatory Exclusivity Expiration:Aug 27, 2018
Regulatory Exclusivity Use:FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET SEIZURES IN ADULTS.
Regulatory Exclusivity Expiration:Nov 8, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Cerilliant
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