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Last Updated: May 25, 2024

TRILEPTAL Drug Patent Profile


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When do Trileptal patents expire, and what generic alternatives are available?

Trileptal is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in TRILEPTAL is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Trileptal

A generic version of TRILEPTAL was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.

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Drug patent expirations by year for TRILEPTAL
Drug Prices for TRILEPTAL

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Drug Sales Revenue Trends for TRILEPTAL

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Recent Clinical Trials for TRILEPTAL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr Cipto Mangunkusumo General HospitalPhase 4
Collaborative Care Initiative, LLCPhase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen HospitalPhase 4

See all TRILEPTAL clinical trials

Pharmacology for TRILEPTAL
Anatomical Therapeutic Chemical (ATC) Classes for TRILEPTAL
Paragraph IV (Patent) Challenges for TRILEPTAL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRILEPTAL Oral Suspension oxcarbazepine 300 mg/5 mL 021285 1 2006-12-26
TRILEPTAL Tablets oxcarbazepine 150 mg, 300 mg and 600 mg 021014 1 2006-05-05

US Patents and Regulatory Information for TRILEPTAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRILEPTAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000 ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000 ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRILEPTAL

See the table below for patents covering TRILEPTAL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0966287 COMPRIMES D'OXACARBAZEPINE ENROBES PAR PELLICULAGE (OXACARBAZEPINE FILM-COATED TABLETS) ⤷  Sign Up
Israel 131039 FORMULATION AND FILM-COATED TABLET COMPRISING OXACARBAZEPINE AND PROCESS FOR PREPARATION THEREOF ⤷  Sign Up
Australia 738030 ⤷  Sign Up
Hong Kong 1024423 ⤷  Sign Up
Poland 355535 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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