NDAN/ASOLUTIONPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Mechanism of Action
protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and…
Pharmacologic Class:
Anti-coagulant
Indications (2)
catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC)incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC)
Clinical Trials (2)
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Started May 2025
200 enrolled
Central Line Associated Blood Stream Infections (CLABSI)
Expanded Access Program for Patients At Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
Catheter-related Bloodstream Infection
Loss of Exclusivity
LOE Date
Apr 15, 2042
196 months away
Patent Expiry
Apr 15, 2042
Exclusivity Expiry
Nov 15, 2033