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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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Federal Trade Commission

Generated: September 16, 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 solifenacin succinate 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 Pharm, Celltrion, Cipla, Glenmark Pharms Inc, Jiangxi Boya Seehot, Msn Labs Pvt Ltd, Qilu Pharm Co Ltd, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, and Astellas, and is included in fifteen 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-one suppliers are listed for this compound. There is one tentative approval for this compound.

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
Generic filers with tentative approvals for SOLIFENACIN SUCCINATE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial10MGTABLET;ORAL
  Try a Free Trial  Try a Free Trial5MGTABLET;ORAL

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

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
Msn Labs Pvt Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210688-002 May 20, 2019 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Alkem Labs Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210224-001 May 20, 2019 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Cipla SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209839-002 May 20, 2019 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   Try a Free Trial
Sciegen Pharms Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 211657-002 May 20, 2019 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Glenmark Pharms Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209239-002 May 20, 2019 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Watson Labs Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 202551-002 May 20, 2019 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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Expired US Patents for solifenacin succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004   Try a Free Trial   Try a Free Trial
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for solifenacin succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0801067 SPC014/2004 Ireland   Try a Free Trial SPC014/2004: 20050803, EXPIRES: 20181215
0801067 CA 2004 00037 Denmark   Try a Free Trial
0801067 SPC/GB04/029 United Kingdom   Try a Free 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   Try a Free Trial 91133, EXPIRES: 20181118
0801067 C00801067/01 Switzerland   Try a Free Trial PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
0801067 04C0032 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Boehringer Ingelheim
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.