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Last Updated: March 18, 2024

APTIOM Drug Patent Profile


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Which patents cover Aptiom, and when can generic versions of Aptiom launch?

Aptiom is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred patent family members in twenty-six countries.

The generic ingredient in APTIOM 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.

Drug patent expirations by year for APTIOM
Drug Prices for APTIOM

See drug prices for APTIOM

Recent Clinical Trials for APTIOM

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

SponsorPhase
SunovionPhase 3
Stanford UniversityPhase 4
SunovionPhase 4

See all APTIOM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for APTIOM
Paragraph IV (Patent) Challenges for APTIOM
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 APTIOM

APTIOM is protected by fifteen US patents.

Patents protecting APTIOM

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Asymmetric catalytic reduction of oxcarbazepine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Asymmetric catalytic reduction of oxcarbazepine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES

Therapeutical uses of eslicarbazepine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE

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 Y ⤷  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 ⤷  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
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 022416-002 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 022416-002 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 022416-001 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 APTIOM

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 APTIOM

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 APTIOM

When does loss-of-exclusivity occur for APTIOM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5917
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06273874
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 20665
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0615970
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 16984
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1277937
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11988
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 15346
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 15346
Estimated Expiration: ⤷  Try a Trial

Patent: 19836
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 95765
Estimated Expiration: ⤷  Try a Trial

Patent: 09502893
Estimated Expiration: ⤷  Try a Trial

Patent: 13173764
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08001291
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5462
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 15346
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 3467
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 39060
Estimated Expiration: ⤷  Try a Trial

Patent: 08107718
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 15346
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0800986
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1362281
Estimated Expiration: ⤷  Try a Trial

Patent: 080036212
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 71556
Estimated Expiration: ⤷  Try a Trial

Patent: 62816
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 15690
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APTIOM around the world.

Country Patent Number Title Estimated Expiration
Australia 2006273874 Asymmetric catalytic reduction of oxcarbazepine ⤷  Try a Trial
South Korea 20170004034 리카르바제핀 아세테이트를 포함하는 경구 투여형 (Oral dosage forms comprising licarbazepine acetate) ⤷  Try a Trial
Portugal 101732 NOVAS DI-HIDRODIBENZOAZEPINAS SUBSTITUIDAS PROCESSO PARA A SUA PREPARACAO COMPOSICOES FARMACEUTICAS QUE AS CONTEM E UTILIZACAO DOS NOVOS COMPOSTOS NA PREPARACAO DE COMPOSICOES FARMACEUTICAS EMPREGUES EM DOENCAS DO SISTEMA NERVOSO ⤷  Try a Trial
South Korea 102116087 ⤷  Try a Trial
United Kingdom 0700773 ⤷  Try a Trial
Portugal 103467 REDUÇÃO CATALÍTICA ASSIMÉTRICA ⤷  Try a Trial
Brazil PI0806568 USO DE ESLICARBAZEPINA OU ACETATO DE ESLICARBAZEPINA, E, COMPOSIÇÃO FARMACÊUTICA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APTIOM

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
2214636 C02214636/01 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 SPC/GB09/047 United Kingdom ⤷  Try a Trial 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
0751129 SPC027/2009 Ireland ⤷  Try a Trial SPC027/2009: 20091119, EXPIRES: 20210627
1915346 C01915346/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
0751129 360 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.