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Generated: February 17, 2019

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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 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.

Drug patent expirations by year for APTIOM
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.

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 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 ➤ Sign Up
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-001 Nov 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 Date
➤ Subscribe Tablets 200 mg, 400 mg, 600 mg and 800 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for APTIOM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/047 United Kingdom ➤ Sign Up 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
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
0 Finland ➤ Sign Up
2009 00023 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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