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Last Updated: May 17, 2022

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 Sunovion Pharms Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three patent family members in twenty-seven countries.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aptiom

A generic version of APTIOM was approved as eslicarbazepine acetate by DR REDDYS LABS LTD on June 29th, 2021.

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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
SunovionPhase 4
Stanford UniversityPhase 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 thirteen US patents.

Patents protecting APTIOM

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Asymmetric catalytic reduction of oxcarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Asymmetric catalytic reduction of oxcarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES

Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES

Therapeutical uses of eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
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
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 Y See Plans and Pricing
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
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 Y 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 APTIOM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
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 022416-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Australia

Patent: 06273874
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0665
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0615970
Estimated Expiration: See Plans and Pricing

Canada

Patent: 16984
Estimated Expiration: See Plans and Pricing

China

Patent: 1277937
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11988
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 15346
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 15346
Estimated Expiration: See Plans and Pricing

Patent: 19836
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9062
Estimated Expiration: See Plans and Pricing

Japan

Patent: 95765
Estimated Expiration: See Plans and Pricing

Patent: 09502893
Estimated Expiration: See Plans and Pricing

Patent: 13173764
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08001291
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5462
Estimated Expiration: See Plans and Pricing

Poland

Patent: 15346
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 3467
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 39060
Estimated Expiration: See Plans and Pricing

Patent: 08107718
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 15346
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0800986
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1362281
Estimated Expiration: See Plans and Pricing

Patent: 080036212
Estimated Expiration: See Plans and Pricing

Spain

Patent: 71556
Estimated Expiration: See Plans and Pricing

Patent: 62816
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 15690
Estimated Expiration: See Plans and Pricing

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
Hungary E032467 See Plans and Pricing
Argentina 003962 DIHIDRODIBENZO/B,F/AZEPINAS ÚTILES EN EL TRATAMIENTO DE ALGUNOS DESÓRDENES DEL SISTEMA NERVIOSO CENTRAL Y PERÍFERICO, MÉTODO PARA PREPARAR DICHOS COMPUESTOS Y SUS COMPOSICIONES FARMACÉUTICAS,Y, SUS USOS See Plans and Pricing
Croatia P20161329 See Plans and Pricing
Netherlands 300406 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APTIOM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915346 C01915346/01 Switzerland See Plans and Pricing PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
0751129 C300406 Netherlands See Plans and Pricing PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129 09C0040 France See Plans and Pricing 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 SPC027/2009 Ireland See Plans and Pricing SPC027/2009: 20091119, EXPIRES: 20210627
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Mallinckrodt
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Baxter
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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.