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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
QuintilesIMS
Argus Health
Boehringer Ingelheim
Queensland Health
Daiichi Sankyo
Fuji
Medtronic
Baxter

Generated: May 24, 2018

DrugPatentWatch Database Preview

APTIOM Drug Profile

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When do Aptiom patents expire, and what generic alternatives are available?

Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in thirty countries.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are ten 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 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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for APTIOM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 200 mg, 400 mg, 600 mg and 800 mg ➤ Subscribe 2017-11-08

Non-Orange Book US Patents for APTIOM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,288,532 Asymmetric catalytic reduction of oxcarbazepine ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for APTIOM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0 Finland ➤ Sign Up
2009 00023 Denmark ➤ Sign Up
C0040 France ➤ Sign Up 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
00406 Netherlands ➤ Sign Up PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Teva
Federal Trade Commission
Boehringer Ingelheim
Queensland Health
Argus Health
Citi
Merck

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