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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Express Scripts
Mallinckrodt
Dow
Baxter

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

VESICARE Drug Profile

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Which patents cover Vesicare, and when can generic versions of Vesicare launch?

Vesicare is a drug marketed by Astellas and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-two countries.

The generic ingredient in VESICARE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.

Drug patent expirations by year for VESICARE
Drug Prices for VESICARE

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Drug Sales Revenue Trends for VESICARE

See drug sales revenues for VESICARE

Recent Clinical Trials for VESICARE

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

SponsorPhase
Baylor Research InstitutePhase 4
The Methodist Hospital SystemPhase 4
Buddhist Tzu Chi General HospitalPhase 2

See all VESICARE clinical trials

Recent Litigation for VESICARE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Astellas Pharma Inc. v. Aurobindo Pharma Limited2018-06-25
Astellas Pharma Inc. v. Cipla Limited2018-06-05

See all VESICARE litigation

Pharmacology for VESICARE
Synonyms for VESICARE
((8r)-1-azabicyclo(2.2.2)octan-8-yl) (1s)-1-phenyl-3,4-dihydro-1h-isoQUINOLINE-2-carboxylate
((8R)-1-azabicyclo(2.2.2)octan-8-yl)(1S)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate
(+)-Solifenacin
(1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl 3,4-Dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate Butanedioic Acid
(1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate
(1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate succinate
(1S)-3,4-Dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic Acid (3R)-1-Azabicyclo-[2.2.2]oct-3-yl Ester Succinate Salt
(1S)-3,4-Dihydro-1-phenyl-d5-2(1H)-isoquinolinecarboxylic Acid (3R)-1-Azabicyclo-[2.2.2]oct-3-yl Ester Hydrochloride
(3R)-1-azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate
[(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate
[(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate hydrochloride
[(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate; butanedioic acid
[(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate;butanedioic acid
[(3R)-quinuclidin-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate; succinic acid
[(8R)-1-azabicyclo[2.2.2]octan-8-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate
1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid
1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid (Solifenacin?Succinate)
180468-39-7
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-1-phenyl-, (3R)-1-azabicyclo(2.2.2)oct-3-yl ester, (1S)-, butanedioate (1:1)
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-1-phenyl-,1-azabicyclo(2.2.2)oct-3-yl ester, (R-(R*,S*))-
242478-37-1
242478-38-2
4058AH
A819262
A8910SQJ1U
AB0139087
AB01565949_02
AC1L4BM0
AC1L4BM3
AC1L50Q6
AC1Q5VRD
AJ-47452
AK160479
AKOS015896445
AKOS015994745
AKOS030241618
AM84825
AN-15595
API0000838
AS-35288
AX8032830
BC677662
BDBM50344284
BDBM50370682
Butanedioic acid, cmpd. with (1S)-(3R)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate (1:1)
Butanedioic acid, compd with (1S)-(3R)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate (1:1)
butanedioic acid; (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylic acid [(3R)-1-azabicyclo[2.2.2]octan-3-yl] ester
C23H26N2O2.ClH
CAS-180468-39-7
CHEBI:135530
CHEBI:32151
CHEMBL1200803
CHEMBL1734
CHEMBL2361425
CS-0371
CS-2661
CS-8096
CTK8F0005
CTK8G3169
D01269
D08522
DB-001095
DB01591
DSSTox_CID_26783
DSSTox_GSID_46783
DSSTox_RID_81901
DTXSID3048289
DTXSID4046783
FBOUYBDGKBSUES-VXKWHMMOSA-N
FT-0657634
FT-0674629
GTPL7483
HY-A0002
HY-A0034
HY-I0230
I06-1893
KKA5DLD701
KS-00000656
KS-00000ZV0
KS-1286
LS-183550
MLS006010416
MolPort-003-850-267
MolPort-003-850-268
NCGC00168778-01
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylatemonosuccinate
RT-015753
RXZMMZZRUPYENV-VROPFNGYSA-N
S0944
s3048
SB17427
SB17428
SCHEMBL109333
SCHEMBL188493
SCHEMBL9971260
SMR004701445
Solifenacin
Solifenacin (hydrochloride)
Solifenacin (INN)
Solifenacin (Succinate)
Solifenacin [INN:BAN]
Solifenacin for system suitability, EuropePharmacopoeia (EP) Reference Standard
Solifenacin hydrochloride
Solifenacin succinate
Solifenacin succinate (JAN/USAN/INN)
Solifenacin succinate [USAN]
Solifenacin Succinate Salt
Solifenacin succinate, >=98% (HPLC)
Solifenacin succinate, EuropePharmacopoeia (EP) Reference Standard
Solifenacin Succinate, United States Pharmacopeia (USP) Reference Standard
Soliten
ST24049293
SW219141-1
Tox21_112639
UNII-A8910SQJ1U
UNII-KKA5DLD701
Vesicare (TN)
Vesicare OD
Vesikur
W-5423
YAUBKMSXTZQZEB-VROPFNGYSA-N
YM 67905
YM 905
YM-53705
YM-67905
YM-905
YM67905
ZINC3936683
Paragraph IV (Patent) Challenges for VESICARE
Tradename Dosage Ingredient NDA Submissiondate
VESICARE TABLET;ORAL solifenacin succinate 021518 2009-04-08

US Patents and Regulatory Information for VESICARE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 AB RX Yes Yes   Start Trial   Start Trial   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 VESICARE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0801067 04C0032 France   Start Trial PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067 CA 2004 00037 Denmark   Start Trial
0801067 91133 Luxembourg   Start Trial 91133, EXPIRES: 20181118
0801067 SPC/GB04/029 United Kingdom   Start Trial PRODUCT NAME: SOLIFENACIN AND/OR PHARMACEUTICALLY ACTIVE SALT THEREOF; REGISTERED: NL RVG 29151 20031216; NL RVG 29152 20031216; UK PL 00166/0197 20040816; UK PL 0016/0198 20040816
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
McKinsey
Dow
Mallinckrodt
Merck

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