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Last Updated: March 19, 2024

Solifenacin succinate - Generic Drug Details


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

Solifenacin succinate is the generic ingredient in three branded drugs marketed by Astellas, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Austarpharma, Breckenridge, Chartwell Rx, Cipla, Glenmark Pharms Inc, Lannett Co Inc, MSN, Qilu, Rising, Sciegen Pharms Inc, Strides Pharma, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-five 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 twenty-three patent family members in twenty-one countries.

There are twenty-nine drug master file entries for solifenacin succinate. Twenty-six suppliers are listed for this compound.

Drug Prices for solifenacin succinate

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Recent Clinical Trials for solifenacin succinate

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SponsorPhase
Longhua HospitalN/A
Shanghai University of Traditional Chinese MedicineN/A
Hikma PharmaPhase 1

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Pharmacology for solifenacin succinate
Medical Subject Heading (MeSH) Categories for solifenacin succinate
Paragraph IV (Patent) Challenges for SOLIFENACIN SUCCINATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VESICARE LS Oral Suspension solifenacin succinate 1 mg/mL 209529 1 2021-05-27
VESICARE Tablets solifenacin succinate 5 mg and 10 mg 021518 1 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
Teva Pharms Usa SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464-001 Apr 2, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210688-001 May 20, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for solifenacin succinate

Country Patent Number Title Estimated Expiration
South Africa 201208762 PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN ⤷  Try a Trial
Eurasian Patent Organization 201291276 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СОЛИФЕНАЦИН ⤷  Try a Trial
Eurasian Patent Organization 023294 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ СОЛИФЕНАЦИН (PHARMACEUTICAL COMPOSITION COMPRISING SOLIFENACIN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for solifenacin succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0801067 SPC/GB04/029 United Kingdom ⤷  Try a 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 04C0032 France ⤷  Try a Trial PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067 C00801067/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.