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Last Updated: April 14, 2021

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TRILEPTAL Drug 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. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty-six patent family members in thirty-three countries.

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.

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

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SponsorPhase
Collaborative Care Initiative, LLCPhase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen HospitalPhase 4
National Alliance on Mental IllnessN/A

See all TRILEPTAL clinical trials

Pharmacology for TRILEPTAL
Paragraph IV (Patent) Challenges for TRILEPTAL
Tradename Dosage Ingredient NDA Submissiondate
TRILEPTAL SUSPENSION;ORAL oxcarbazepine 021285 2006-12-26
TRILEPTAL TABLET;ORAL oxcarbazepine 021014 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   Start Trial   Start Trial Y   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
>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 021014-002 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001   Start Trial   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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