NDAORALTABLET
Approved
Jan 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
URISPAS (flavoxate hydrochloride) by Johnson & Johnson is clinical pharmacology flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. First approved in 1970.
Drug data last refreshed 19h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
URISPAS (flavoxate hydrochloride) is an oral antispasmodic tablet approved in 1970 that counteracts smooth muscle spasm of the urinary tract through direct muscle relaxation. It is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, and urinary frequency associated with urological conditions. The drug reaches peak effect approximately 112 minutes after administration with 57% urinary excretion within 24 hours.
LOE Approaching
Product is approaching loss of exclusivity with 30% competitive pressure; commercial team likely focused on generic transition planning and managed care retention strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on URISPAS offers limited growth trajectory as the product approaches loss of exclusivity; career value lies in managing mature portfolio transition, generic negotiation, and market access strategy. This role is better suited for professionals seeking stability and operational expertise rather than launch or innovation-driven advancement.
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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.