TRILEPTAL Drug Patent Profile

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. Twenty-eight 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 9^th, 2007.

Summary for TRILEPTAL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	24
Patent Applications:	4,746
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRILEPTAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRILEPTAL
What excipients (inactive ingredients) are in TRILEPTAL?	TRILEPTAL excipients list
DailyMed Link:	TRILEPTAL at DailyMed

See drug prices for TRILEPTAL

See drug sales revenues for TRILEPTAL

Recent Clinical Trials for TRILEPTAL

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital	Phase 4
Collaborative Care Initiative, LLC	Phase 4

See all TRILEPTAL clinical trials

Pharmacology for TRILEPTAL

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for TRILEPTAL

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	AB	RX	Yes	Yes
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-001	Jan 14, 2000	AB	RX	Yes	No
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-002	Jan 14, 2000	AB	RX	Yes	No

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
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-002	Jan 14, 2000
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000

International Patents for TRILEPTAL

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	509391	Oxacarbazepine film-coated tablets further comprising a hydrophobic permeable outer coating containing iron oxide from 0.3 to 0.9 mg per tablet
Portugal	1239832
China	1216594
Uruguay	24888	TABLETAS DE OXACARBAZEPINA RECUBIERTAS DE PELICULA
Denmark	1239832
Czech Republic	298840	Farmaceutické prípravky s obsahem oxakarbazepinu a zpusob jejich výroby (Oxacarbazepine containing pharmaceutical compositions and process of their preparation)