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Last Updated: August 8, 2020

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VESICARE Drug Profile

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When do Vesicare patents expire, and what generic alternatives are available?

Vesicare is a drug marketed by Astellas and is included in two NDAs.

The generic ingredient in VESICARE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Vesicare

A generic version of VESICARE was approved as solifenacin succinate by TEVA PHARMS USA on April 2nd, 2014.

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Drug patent expirations by year for VESICARE
Drug Prices for VESICARE

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Drug Sales Revenue Trends for VESICARE

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Recent Clinical Trials for VESICARE

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

Baylor Research InstitutePhase 4
The Methodist Hospital SystemPhase 4
Buddhist Tzu Chi General HospitalPhase 2

See all VESICARE clinical trials

Pharmacology for VESICARE
Paragraph IV (Patent) Challenges for VESICARE
Tradename Dosage Ingredient NDA Submissiondate
VESICARE TABLET;ORAL solifenacin succinate 021518 2009-04-08

US Patents and Regulatory Information for VESICARE

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   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
Astellas VESICARE LS solifenacin succinate SUSPENSION;ORAL 209529-001 May 26, 2020 RX Yes Yes   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 VESICARE

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 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 CA 2004 00037 Denmark   Start Trial
0801067 91133 Luxembourg   Start Trial 91133, EXPIRES: 20181118
0801067 SPC014/2004 Ireland   Start Trial SPC014/2004: 20050803, EXPIRES: 20181215
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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