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Last Updated: March 19, 2024

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, and Hetero Labs Ltd V, and is included in five 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.

Recent Clinical Trials for eslicarbazepine acetate

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

SponsorPhase
Whanin Pharmaceutical CompanyPhase 1
Stanford UniversityPhase 4
SunovionPhase 4

See all eslicarbazepine acetate clinical trials

Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial600MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial400MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET;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
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

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 211199-002 Oct 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-001 Nov 8, 2013 AB RX Yes 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

Expired US Patents for eslicarbazepine acetate

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

EU/EMA Drug Approvals for eslicarbazepine acetate

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

Supplementary Protection Certificates for eslicarbazepine acetate

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