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Last Updated: August 12, 2020

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APTIOM Drug 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 nine patents protecting this drug and one Paragraph IV challenge.

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

US ANDA Litigation and Generic Entry Outlook for Aptiom

Aptiom was eligible for patent challenges on November 8, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2026. This may change due to patent challenges or generic licensing.

There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (eslicarbazepine acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for APTIOM
Drug Prices for APTIOM

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Generic Entry Opportunity Date for APTIOM
Generic Entry Date for APTIOM*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Paragraph IV (Patent) Challenges for APTIOM
Tradename Dosage Ingredient NDA Submissiondate
APTIOM TABLET;ORAL eslicarbazepine acetate 022416 2017-11-08

US Patents and Regulatory Information for APTIOM

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 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for APTIOM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0751129 360 Finland   Start Trial
0751129 SPC027/2009 Ireland   Start Trial SPC027/2009: 20091119, EXPIRES: 20210627
0751129 09C0040 France   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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Mallinckrodt
Express Scripts
Baxter
Moodys

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.