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Generated: September 26, 2017

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 five patents protecting this drug. Additional details are available on the APTIOM profile page.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are nine 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 NDA: 022416

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
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 63402-202-30 30 TABLET in 1 BOTTLE (63402-202-30)
APTIOM
eslicarbazepine acetate
TABLET;ORAL 022416 NDA Sunovion Pharmaceuticals Inc. 63402-204 63402-204-28 4 BLISTER PACK in 1 CARTON (63402-204-28) > 7 TABLET in 1 BLISTER PACK (63402-204-07)

Summary 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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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Dow
Argus Health
Cipla
Queensland Health
Accenture
US Department of Justice
Medtronic
McKinsey
QuintilesIMS

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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