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Last Updated: May 8, 2021

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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-eight 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.

DrugPatentWatch® 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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DrugPatentWatch® Estimated 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
Stanford UniversityPhase 4
SunovionPhase 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 022416-003 Nov 8, 2013 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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   Get Started for $10
0751129 09C0040 France   Get Started for $10 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 CA 2009 00023 Denmark   Get Started for $10
0751129 C300406 Netherlands   Get Started for $10 PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129 SPC/GB09/047 United Kingdom   Get Started for $10 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   Get Started for $10 SPC027/2009: 20091119, EXPIRES: 20210627
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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