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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Harvard Business School

Last Updated: December 5, 2019

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 nineteen 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
Drug Prices for APTIOM

See drug prices 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.

Recent Clinical Trials for APTIOM

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

SponsorPhase
SunovionPhase 3
SunovionPhase 4
Stanford UniversityPhase 4

See all APTIOM clinical trials

Recent Litigation for APTIOM

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. Hetero Labs Limited2018-03-02

See all APTIOM litigation

Synonyms for APTIOM
(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 (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
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 APTIOM
Tradename Dosage Ingredient NDA Submissiondate
APTIOM TABLET;ORAL eslicarbazepine acetate 022416

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   Start Trial   Start Trial   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
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-001 Nov 8, 2013 RX Yes No   Start Trial   Start Trial Y   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
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 RX Yes No   Start Trial   Start Trial Y 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 APTIOM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0751129 360 Finland   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 CA 2009 00023 Denmark   Start Trial
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 C300406 Netherlands   Start Trial PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129 SPC027/2009 Ireland   Start Trial SPC027/2009: 20091119, EXPIRES: 20210627
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Johnson and Johnson
McKesson
Colorcon
Medtronic

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