NDAORALSUSPENSIONPriority Review
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
23/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VESICARE LS is an oral suspension formulation of solifenacin succinate, an antimuscarinic agent approved in 2020 for overactive bladder (OAB) symptoms. The drug works by blocking muscarinic receptors to reduce urinary urgency, frequency, and incontinence. The liquid formulation enables flexible dosing and may improve adherence in patients with swallowing difficulties.
$0.032BPart D
Peak4.9 years to LOEAt peak lifecycle maturity with modest Part D penetration; brand team likely optimizing market share against established competitors rather than driving growth.
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 (20)
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
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Started Apr 2013
126 enrolled
Urinary Tract Infection
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
Started Sep 2012
72 enrolled
Phase 1BioavailabilityHealthy Subjects
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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.