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Generated: November 20, 2018

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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 twelve 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
Generic Entry Opportunity Date for 022416
Generic Entry Date for 022416*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

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 63402-202-28 4 BLISTER PACK in 1 CARTON (63402-202-28) > 7 TABLET in 1 BLISTER PACK (63402-202-07)
APTIOM eslicarbazepine acetate TABLET;ORAL 022416 NDA Sunovion Pharmaceuticals Inc. 63402-202 63402-202-30 30 TABLET in 1 BOTTLE (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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