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Last Updated: November 29, 2022

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 Sunovion Pharms Inc and Dr Reddys, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eslicarbazepine acetate has one hundred and three patent family members in twenty-seven countries.

There are twelve drug master file entries for eslicarbazepine acetate. One supplier is 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
See Plans and PricingSee Plans and Pricing400MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing800MGTABLET;ORAL

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

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
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys ESLICARBAZEPINE ACETATE eslicarbazepine acetate TABLET;ORAL 211238-003 Jun 29, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-001 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
>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

International Patents for eslicarbazepine acetate

Country Patent Number Title Estimated Expiration
Argentina 055917 PROCESO DE REDUCCION CATALITICA ASIMETRICA PARA PREPARAR LOS ISOMEROS (S)-(+) Y (R)-(-) DEL COMPUESTO (10,11-DIHIDRO-10-HIDROXI-5-H DIBENZ [B.F] AZEPIN-5-CARBOXAMIDA] See Plans and Pricing
South Korea 101519040 See Plans and Pricing
Japan 2009502893 See Plans and Pricing
Russian Federation 2488397 ТЕРАПЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ ЭСЛИКАРБАЗЕПИНА (THERAPEUTIC USE OF ESLICARBAZEPINE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eslicarbazepine acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0751129 C300406 Netherlands See Plans and Pricing PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129 SPC/GB09/047 United Kingdom See Plans and Pricing PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421
1915346 C01915346/01 Switzerland See Plans and Pricing PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
2214636 C02214636/01 Switzerland See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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