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McKinsey
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021014

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NDA 021014 describes TRILEPTAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRILEPTAL profile page.

The generic ingredient in TRILEPTAL is oxcarbazepine. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 021014
Tradename:TRILEPTAL
Applicant:Novartis
Ingredient:oxcarbazepine
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021014
Suppliers and Packaging for NDA: 021014
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRILEPTAL oxcarbazepine TABLET;ORAL 021014 NDA Novartis Pharmaceuticals Corporation 0078-0337 N 0078-0337-06
TRILEPTAL oxcarbazepine TABLET;ORAL 021014 NDA Novartis Pharmaceuticals Corporation 0078-0337 N 0078-0337-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 12, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 12, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 12, 2018Product Flag?Substance Flag?Delist Request?Y

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Daiichi Sankyo
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US Army

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