drug
leniolisib
Marketedupdated 3mo agoby Pharming Group NV
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying leniolisib
- phase2Leniolisib for Immune Dysregulation in PIDs
- phase2Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
- phase2Leniolisib for Immune Dysregulation in CVID
- phase3Pediatric Patients Aged 1 to 6 Years With APDS
- phase3Pediatric Patients Aged 4 to 11 Years With APDS
- phase3An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 24, 2028
~1.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (1)
- Feb 19, 2032compositionUS 8653092
FDA exclusivities (2)
- Mar 24, 2030ODE-430Orphan Drug (7y)3.6y
- Mar 24, 2028NCENew Chemical Entity (5y)1.6y
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