You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Boehringer Ingelheim
AstraZeneca
Express Scripts
Merck

Last Updated: February 22, 2024

Eslicarbazepine acetate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial600MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial400MGTABLET;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
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 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 022416-001 Nov 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 Y ⤷  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 022416-003 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
Sumitomo Pharma Am APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 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

International Patents for eslicarbazepine acetate

Country Patent Number Title Estimated Expiration
Spain 2606952 ⤷  Try a Trial
Australia 2008317584 Oral dosage forms comprising licarbazepine acetate ⤷  Try a Trial
Portugal 103467 REDUÇÃO CATALÍTICA ASSIMÉTRICA ⤷  Try a Trial
South Korea 20170004034 리카르바제핀 아세테이트를 포함하는 경구 투여형 (Oral dosage forms comprising licarbazepine acetate) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eslicarbazepine acetate

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Harvard Business School
Colorcon
Moodys
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.