TOVIAZ (fesoterodine fumarate)
Toviaz helps patients with overactive bladder who experience symptoms like urgency, frequency, and urge urinary incontinence. It is also used for children six years and older weighing more than 25 kg who have neurogenic detrusor overactivity. This medication is prescribed to manage these bladder control issues in both adult and pediatric populations.
How TOVIAZ Works
This drug works by blocking muscarinic receptors, which are responsible for the contraction of smooth muscles in the bladder. After it is swallowed, the body quickly converts it into an active metabolite that competes for these receptor sites. By inhibiting these receptors, the medication helps reduce the muscle activity that leads to bladder symptoms.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-10-31
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
TOVIAZ Approval History
What TOVIAZ Treats
2 indicationsTOVIAZ is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Neurogenic Detrusor Overactivity
TOVIAZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TOVIAZ
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01786967 URGE results posted | 13-2066 1R03AG042335-01, Pro00036147 | Ph 3 | completed | Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE) |
| NCT01566760 | A0221069 | Ph 1 | completed | A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers |
| NCT01925456 PfizerOABLUT | 813672 | Ph 1 | completed | Validation of Instruments for Pragmatic Clinical Trials for Overactive Bladder |
| NCT01605617 results posted | 11-004589 | Ph 4 | terminated | Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate |
| NCT00798434 SOFIA results posted | A0221045 | Ph 4 | completed | A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. |
| NCT00832650 results posted | A0221057 | Ph 1 | terminated | Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit |
| NCT00658684 results posted | A0221006 A0221006 | Ph 3 | completed | Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOVIAZ FDA Label Details
Indications & Usage
FDA Label (PDF)TOVIAZ is indicated for the treatment of Overactive Bladder; Neurogenic Detrusor Overactivity.
TOVIAZ Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for TOVIAZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 24 active patents
Trial Analysis
- • 11 total trials
- • Stage: Declining
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment