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Serving hundreds of leading biopharmaceutical companies globally:

Teva
AstraZeneca
Moodys
Colorcon
Baxter
McKinsey
Healthtrust
Julphar
Express Scripts

Generated: June 18, 2018

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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 solifenacin succinate patent protection?

Solifenacin succinate
is the generic ingredient in two branded drugs marketed by Teva Pharms Usa and Astellas, and is included in two 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. Five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for solifenacin succinate
International Patents:32
US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 30
Suppliers / Packagers: 5
Bulk Api Vendors: 93
Clinical Trials: 238
Patent Applications: 1,993
DailyMed Link:solifenacin succinate at DailyMed
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
AX8032830
BC677662
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
HE069953
HE328035
HY-A0002
I06-1672
KKA5DLD701
KS-00000656
KS-1286
LS-183550
MFCD09952287
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
SCHEMBL109333
SCHEMBL111525
SCHEMBL6478242
SMR004701445
Solifenacin
Solifenacin (Succinate)
Solifenacin succinate (JAN/USAN/INN)
Solifenacin succinate [USAN]
Solifenacin Succinate Salt
SOLIFENACIN; SUCCINIC ACID
Solifenacinsuccinate
ST24049293
UNII-KKA5DLD701
Vesicare
Vesicare (TN)
Vesicare OD
Vesikur
W-5423
YM 905
YM-53705
YM-905
YM67905
YM905
Tentative approvals for SOLIFENACIN SUCCINATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET;ORAL

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
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva Pharms Usa SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464-001 Apr 2, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva Pharms Usa SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464-002 Apr 2, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for solifenacin succinate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,174,896 Quinuclidine derivatives and medicinal composition thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for solifenacin succinate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
133 Luxembourg ➤ Try a Free Trial 91133, EXPIRES: 20181118
C0032 France ➤ Try a Free Trial PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
C014/2004 Ireland ➤ Try a Free Trial SPC014/2004: 20050803, EXPIRES: 20181215
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chinese Patent Office
Chubb
Citi
Cipla
Cantor Fitzgerald
QuintilesIMS
McKinsey
Accenture

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