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Last Updated: November 20, 2019

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 four suppliers. There is one patent 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 twenty-one drug master file entries for this compound. Twenty 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:0
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 0078-0337-05 100 TABLET, FILM COATED in 1 BOTTLE (0078-0337-05)
TRILEPTAL oxcarbazepine TABLET;ORAL 021014 NDA Novartis Pharmaceuticals Corporation 0078-0337 0078-0337-06 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0337-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0337-61)
Paragraph IV (Patent) Challenges for 021014
Tradename Dosage Ingredient NDA Submissiondate
TRILEPTAL TABLET;ORAL oxcarbazepine 021014 2006-05-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 14, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021014

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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