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Last Updated: December 8, 2019

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Solifenacin succinate - Generic Drug Details

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What are the generic drug sources for solifenacin succinate and what is the scope of patent protection?

Solifenacin succinate is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Celltrion, Cipla, Glenmark Pharms Inc, Jiangxi Boya Seehot, Msn Labs Pvt Ltd, Qilu Pharm Co Ltd, Sciegen Pharms Inc, Strides Pharma, Teva Pharms Usa, Unichem Labs Ltd, Watson Labs Inc, and Astellas, and is included in seventeen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Solifenacin succinate has thirty-two patent family members in twenty-two countries.

There are thirty drug master file entries for solifenacin succinate. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for solifenacin succinate

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Recent Clinical Trials for solifenacin succinate

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SponsorPhase
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaPhase 4
Ono Pharmaceutical Co. LtdPhase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 4

See all solifenacin succinate clinical trials

Recent Litigation for solifenacin succinate

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 solifenacin succinate litigation

Generic filers with tentative approvals for SOLIFENACIN SUCCINATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;ORAL

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

Pharmacology for solifenacin succinate
Medical Subject Heading (MeSH) Categories for solifenacin succinate
Synonyms for solifenacin succinate
(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-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-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
1-azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate; butanedioic acid
1-azabicyclo[2.2.2]octan-3-yl 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
1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid (Solifenacin?Succinate)
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-1-phenyl-, (3R)-1-azabicyclo(2.2.2)oct-3-yl ester, (1S)-, butanedioate (1:1)
242478-38-2
A817166
A819262
AB0139087
AC-747
AC1L50Q6
AC1L9FFO
AC1Q5VRD
AK160479
AKOS005146515
AKOS015896172
AKOS015994745
AM84825
AN-15595
AS-12203
AS-35288
AX8032830
BC677662
BCP21989
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
butanedioic acid; 1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylic acid 1-azabicyclo[2.2.2]octan-3-yl ester
C23H26N2O2.C4H6O4
CHEBI:32151
CHEMBL1200803
CS-0371
CTK8G3169
D01269
FT-0657634
HY-A0002
I06-1672
KKA5DLD701
KS-00000656
KS-1286
LS-183550
MLS006010416
MolPort-003-850-268
MolPort-009-682-972
PubChem18822
PubChem20236
Q-101001
quinuclidin-3-yl (1S)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate succinate
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylatemonosuccinate
RL02770
RXZMMZZRUPYENV-VROPFNGYSA-N
S0944
s3048
SB17428
SCHEMBL109333
SCHEMBL111525
SCHEMBL6478242
SMR004701445
Solifenacin (Succinate)
Solifenacin for system suitability, EuropePharmacopoeia (EP) Reference Standard
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
ST24049293
SW219141-1
UNII-KKA5DLD701
Vesicare
Vesicare (TN)
Vesicare OD
Vesikur
W-5423
YM 905
YM-53705
YM-67905
YM-905
YM67905
YM905
Paragraph IV (Patent) Challenges for SOLIFENACIN SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
VESICARE TABLET;ORAL solifenacin succinate 021518 2009-04-08

US Patents and Regulatory Information for solifenacin succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 212214-002 Sep 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210224-002 May 20, 2019 AB RX No 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
Ajanta Pharma Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205483-002 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209239-001 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205575-001 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 211657-002 May 20, 2019 AB RX No No   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 solifenacin succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0801067 C00801067/01 Switzerland   Start Trial PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
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
0801067 91133 Luxembourg   Start Trial 91133, EXPIRES: 20181118
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 SPC014/2004 Ireland   Start Trial SPC014/2004: 20050803, EXPIRES: 20181215
0801067 CA 2004 00037 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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