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Toviaz (Fesoterodine Fumarate)
Fesoterodine Fumarate (Toviaz), marketed by Pfizer, is an overactive bladder treatment that competes in a crowded market with several off-patent generics and one patent-protected competitor, solifenacin. A key strength of Toviaz is its mechanism of action, which effectively blocks acetylcholine to relax the bladder muscle, potentially offering a more tolerable side effect profile compared to older anticholinergics. The primary risk facing Toviaz is the impending key composition patent expiry in 2028, which could lead to increased competition from generics and erode market share.
At a glance
| Generic name | Fesoterodine Fumarate |
|---|---|
| Sponsor | Pfizer |
| Drug class | fesoterodine |
| Target | Muscarinic acetylcholine receptor M2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2008 |
Approved indications
- Overactive Bladder
Common side effects
- Dry mouth
- Constipation
- Nausea
- Dyspepsia
- Abdominal pain upper
- Urinary tract infection
- Upper respiratory tract infection
- Dry eyes
- Dysuria
- Urinary retention
- Cough
- Dry throat
Drug interactions
- antimuscarinic drugs
- strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
- moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice)
- weak CYP3A4 inhibitors (e.g., cimetidine)
- CYP3A4 inducers (e.g., rifampin, carbamazepine)
- CYP2D6 inhibitors
Key clinical trials
- Deprescribing dRrugs for Overactive Bladder in General Practice (DROP) (NA)
- Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis (EARLY_PHASE1)
- Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
- A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
- Fall Prevention in Older Adults With OAB (PHASE4)
- Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics (PHASE4)
- Drug Use Investigation for Toviaz
- BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Toviaz CI brief — competitive landscape report
- Toviaz updates RSS · CI watch RSS
- Pfizer portfolio CI