VESICARE LS

Peak

solifenacin succinate

NDAORALSUSPENSIONPriority Review
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

Clinical Trials (5)

NCT05767632Phase 1Completed

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
NCT02045862Phase 3Completed

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
NCT01972841Phase 3Completed

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
NCT02094703Phase 4Unknown

The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

Started Apr 2013
126 enrolled
Urinary Tract Infection
NCT02010944Phase 1Completed

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

Loss of Exclusivity

LOE Date
May 18, 2031
63 months away
Patent Expiry
May 18, 2031

Patent Records (1)

Patent #ExpiryTypeUse Code
9918970
May 18, 2031
Product