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Last Updated: August 9, 2020

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Eslicarbazepine acetate - Generic Drug Details

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What are the generic drug sources for eslicarbazepine acetate and what is the scope of freedom to operate?

Eslicarbazepine acetate is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eslicarbazepine acetate has one hundred and twenty patent family members in thirty countries.

There are twelve drug master file entries for eslicarbazepine acetate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for eslicarbazepine acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Whanin Pharmaceutical CompanyPhase 1
SunovionPhase 4
Stanford UniversityPhase 4

See all eslicarbazepine acetate clinical trials

Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial800MGTABLET;ORAL
  Start Trial  Start Trial600MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for eslicarbazepine acetate

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 022416-001 Nov 8, 2013 RX Yes No   Start Trial   Start Trial   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
>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 eslicarbazepine acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0751129 CA 2009 00023 Denmark   Start Trial
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
0751129 360 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Colorcon
Express Scripts
Dow
Merck

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