NDAINTRAVESICALSYSTEMPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Clinical Trials (1)
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Started Dec 2003
90 enrolled
Superficial Bladder Cancer
Loss of Exclusivity
LOE Date
Aug 19, 2034
103 months away
Patent Expiry
Aug 19, 2034
Exclusivity Expiry
Sep 9, 2028