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Last Updated: July 23, 2021

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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 freedom to operate?

Solifenacin succinate is the generic ingredient in three branded drugs marketed by Astellas, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Celltrion, Cipla, Glenmark Pharms Inc, Jiangxi Boya Seehot, MSN, Qilu, Rising, Sciegen Pharms Inc, Strides Pharma, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-one 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-four patent family members in twenty-two countries.

There are thirty drug master file entries for solifenacin succinate. Eight suppliers are listed for this compound.

Drug Prices for SOLIFENACIN SUCCINATE

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Recent Clinical Trials for SOLIFENACIN SUCCINATE

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

SponsorPhase
Centre Hospitalier Universitaire VaudoisPhase 4
Brigitte SchürchPhase 4
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaPhase 4

See all SOLIFENACIN SUCCINATE clinical trials

Pharmacology for SOLIFENACIN SUCCINATE
Medical Subject Heading (MeSH) Categories for SOLIFENACIN SUCCINATE
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
Teva Pharms Usa SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464-001 Apr 2, 2014 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Breckenridge SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209818-002 May 20, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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 it Free 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 C00801067/01 Switzerland ⤷  Try it Free PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
0801067 04C0032 France ⤷  Try it Free 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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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Medtronic
McKinsey
Dow
Mallinckrodt

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