Eslicarbazepine acetate - Generic Drug Details

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What are the generic sources for eslicarbazepine acetate and what is the scope of patent protection?

Eslicarbazepine acetate is the generic ingredient in two branded drugs marketed by Sumitomo Pharma Am, Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, and Torrent, and is included in seven NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eslicarbazepine acetate has one hundred patent family members in twenty-six countries.

There are twelve drug master file entries for eslicarbazepine acetate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for eslicarbazepine acetate

International Patents:	100
US Patents:	11
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	51
Patent Applications:	433
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eslicarbazepine acetate
What excipients (inactive ingredients) are in eslicarbazepine acetate?	eslicarbazepine acetate excipients list
DailyMed Link:	eslicarbazepine acetate at DailyMed

Recent Clinical Trials for eslicarbazepine acetate

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

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

See all eslicarbazepine acetate clinical trials

Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	600MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	200MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for eslicarbazepine acetate

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

Anatomical Therapeutic Chemical (ATC) Classes for eslicarbazepine acetate

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ESLICARBAZEPINE ACETATE

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

US Patents and Regulatory Information for eslicarbazepine acetate

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Glossary

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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
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211186-003	Aug 3, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	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 eslicarbazepine acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for eslicarbazepine acetate

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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

International Patents for eslicarbazepine acetate

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Country	Patent Number	Title	Estimated Expiration
Japan	2018172407	酢酸リカルバゼピンを含む経口剤形 (ORAL DOSAGE FORM COMPRISING LICARBAZEPINE ACETATE)	⤷ Sign Up
Australia	2005331690	Methods of preparing pharmaceutical compositions comprising eslicarbazepine acetate and methods of use	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007012793		⤷ Sign Up
Mexico	2009007486	USOS TERAPEUTICOS DE ESLICARBAZEPINA. (THERAPEUTICAL USES OF ESLICARBAZEPINE.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for eslicarbazepine acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0751129	09C0040	France	⤷ Sign Up	PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421
2214636	C02214636/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
0751129	C300406	Netherlands	⤷ Sign Up	PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
1915346	C01915346/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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