Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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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 patent protection?

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 nineteen 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

Recent Litigation for eslicarbazepine acetate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bial - Portela & CA S.A. v. SPH Shanghai Zhongxi Pharmaceutical Co., Ltd.2018-05-21
BIAL - PORTELA & CA S.A. v. Apotex Inc.2018-03-09
BIAL - PORTELA & CA S.A. v. Dr. Reddy's Laboratories, Ltd.2018-03-02

See all eslicarbazepine acetate litigation

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.

Synonyms for eslicarbazepine acetate
(10S)-10-(Acetyloxy)-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide
(10S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide
(10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate
(S)-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide
(S)-5-Carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate
[(5S)-11-carbamoyl-5,6-dihydrobenzo[b][1]benzazepin-5-yl] acetate
10-Acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide
10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate
236395-14-5
5H-Dibenz[b,f]azepine-5-carboxamide,10-(acetyloxy)-10,11-dihydro-, (10S)-
5H-Dibenz9b,f)azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10S)-
AC1L452K
Acetic acid (S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl ester
Acetic acid 5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10(S)-yl ester
AK163092
AKOS005145781
AN-6410
Aptiom
Aptiom (TN)
AS-14058
AX8243774
BDBM50240669
BEA68ZVB2K
BIA 2-093
BIA 2-093, >=98% (HPLC), solid
BIA 2093
BIA-2-093
CCG-222406
CHEBI:87016
CHEMBL87992
CS-2942
CTK4F1953
D09612
DB09119
DTXSID90178308
E1046
Eslicarbazapine Acetate
Eslicarbazepine (acetate)
Eslicarbazepine acetate (USAN)
Eslicarbazepine acetate [USAN]
Exalief
exelief
FT-0667969
HMS3263M06
HY-B0703
J-015175
J90004
KS-00000QYO
LP01102
MolPort-005-942-413
NCGC00165752-01
NCGC00165752-02
NCGC00261787-01
QIALRBLEEWJACW-INIZCTEOSA-N
RT-011499
S-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide
s4657
SB18907
SCHEMBL250594
SEP - 0002093
Sep 0002093
SEP-0002093
ST24036220
Stedesa
Tox21_501102
UNII-BEA68ZVB2K
X5819
Zebinix
Zebinix (TN)
ZINC7295
Paragraph IV (Patent) Challenges for ESLICARBAZEPINE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
APTIOM TABLET;ORAL eslicarbazepine acetate 022416

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 022416-002 Nov 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 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 Y   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   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 SPC027/2009 Ireland   Start Trial SPC027/2009: 20091119, EXPIRES: 20210627
0751129 C300406 Netherlands   Start Trial PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129 SPC/GB09/047 United Kingdom   Start Trial 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 360 Finland   Start Trial
0751129 CA 2009 00023 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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