drug
danicopan
Marketedupdated 3mo agoby Alexion Pharmaceuticals Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying danicopan
- phase3A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
- —Danicopan Early Access Program
- —Long-term Safety of Danicopan: IPIG Registry-based Cohort Study
- —Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data
- phase3Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis
- phase2A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- phase3Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
- phase2Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 29, 2029
~2.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (4)
- Aug 2, 2038method-of-use (U-3933)US 12076319
- Aug 2, 2038method-of-use (U-3933)US 12076319
- Feb 25, 2035compositionUS 9796741
- Feb 25, 2035compositionUS 9796741
FDA exclusivities (4)
- Mar 29, 2031ODE-476Orphan Drug (7y)4.6y
- Mar 29, 2031ODE-476Orphan Drug (7y)4.6y
- Mar 29, 2029NCENew Chemical Entity (5y)2.6y
- Mar 29, 2029NCENew Chemical Entity (5y)2.6y
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