ESLICARBAZEPINE ACETATE Drug Patent Profile

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Eslicarbazepine Acetate is a drug marketed by Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, and Torrent. and is included in five NDAs.

The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.

A generic version of ESLICARBAZEPINE ACETATE was approved as eslicarbazepine acetate by DR REDDYS on June 29^th, 2021.

US Patents:	0
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	51
Patent Applications:	282
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESLICARBAZEPINE ACETATE
DailyMed Link:	ESLICARBAZEPINE ACETATE at DailyMed

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Sponsor	Phase
Whanin Pharmaceutical Company	Phase 1
Stanford University	Phase 4
Sunovion	Phase 4

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APTIOM	Tablets	eslicarbazepine acetate	200 mg, 400 mg, 600 mg and 800 mg	022416	7	2017-11-08

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199-001	Oct 6, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Torrent	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211227-002	Feb 27, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211236-003	Dec 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199-004	Oct 6, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211238-004	Jun 29, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Torrent	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211227-004	Feb 27, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211236-004	Dec 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
BIAL - Portela & Ca, S.A.	Zebinix	eslicarbazepine acetate	EMEA/H/C/000988 Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.	Authorised	no	no	no	2009-04-21
BIAL - Portela Ca, S.A.	Exalief	eslicarbazepine acetate	EMEA/H/C/000987 Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.	Withdrawn	no	no	no	2009-04-21
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal