NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
10
Data completeness
5/8 — Partial
TOVIAZ (fesoterodine fumarate) by Pfizer is antagonist. First approved in 2008.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOVIAZ (fesoterodine fumarate) is an oral extended-release antimuscarinic agent approved in 2008 for overactive bladder. It works by antagonizing muscarinic receptors in the bladder smooth muscle to reduce involuntary contractions. The drug is a prodrug rapidly hydrolyzed to its active metabolite, 5-hydroxymethyl tolterodine, which drives its therapeutic effect.
$9MPart D
LOE ApproachingDeclining
1.2 years to LOEProduct is in late-stage commercial decline with ~1.2 years to LOE, signaling shrinking team resources and transition focus toward generic competition management.
Mechanism of Action
antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in contractions of urinary…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
Started Nov 2019
18 enrolled
Neurogenic Detrusor Overactivity
Drug Use Investigation for Toviaz
Started Oct 2013
2,521 enrolled
Overactive Bladder (OAB)
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Started May 2012
24 enrolled
Urinary Bladder, Overactive
Premarin Versus Toviaz for Treatment of Overactive Bladder
Started Apr 2012
90 enrolled
Overactive Bladder
Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy
Started Dec 2010
781 enrolled
Urinary Bladder, Overactive
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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.