NDAORALTABLET1 Generic Approved
Approved
Nov 2004
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
41
Data completeness
3/8 — Basic
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VESICARE (solifenacin succinate) is an oral antimuscarinic small molecule approved in 2004 for overactive bladder, neurogenic bladder, and related lower urinary tract symptoms. It works by blocking muscarinic receptors to reduce bladder muscle contractions and increase urine storage capacity. The drug treats a broad patient population experiencing urinary incontinence and urgency.
$6MPart D
LOE ApproachingDeclining
LOE-approaching lifecycle signals consolidation of field teams and shift toward lifecycle management and generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (41)
Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
Started May 2022
30 enrolled
Healthy
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
Started Mar 2014
1,829 enrolled
Urinary Bladder OveractiveOveractive BladderUrgency Incontinence+1 more
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
Started Nov 2013
3,527 enrolled
Urinary Bladder OveractiveUrinary Bladder Diseases\Urologic DiseasesOveractive Bladder+1 more
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
Started Sep 2013
23 enrolled
Neurogenic Detrusor OveractivityPediatric
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Started Apr 2013
126 enrolled
Urinary Tract Infection
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.