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  1. pharmadog
  2. ›drugs
  3. ›Oxlumo
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lumasiran

Marketedupdated 3mo ago
by $ALNY ALNYLAM PHARMACEUTICALS, INC.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying lumasiran

  • phase3A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1completedn=21
  • phase3A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1completedn=18
  • phase2Lumasiran in Hyperoxalaemic Patients on Haemodialysisrecruitingn=50
  • phase3A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1completedn=39
  • phase2A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levelsterminatedn=2
  • phase2An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1completedn=20
  • —Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1approved for marketing

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 23, 2027
~1.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (14)

  • Nov 20, 2038compositionUS 11261447
  • Oct 9, 2035compositionUS 10478500
  • Oct 9, 2035compositionUS 11446380
  • Aug 14, 2035compositionUS 10612024
  • Aug 14, 2035compositionUS 10612027
  • Aug 14, 2035compositionUS 11401517
  • Dec 26, 2034method-of-use (U-2995)US 10435692
  • Dec 26, 2034compositionUS 10465195
  • Dec 26, 2034compositionUS 10487330
  • Dec 26, 2034compositionUS 11060093
  • Dec 26, 2034compositionUS 9828606
  • Dec 12, 2029compositionUS 81060223.3y
  • Dec 4, 2028compositionUS 88289562.3y
  • Aug 24, 2028compositionUS 101319072.0y

FDA exclusivities (2)

  • Oct 6, 2029ODE-415Orphan Drug (7y)3.1y
  • Nov 23, 2027ODE-339Orphan Drug (7y)1.3y

News(0)

no news has mentioned this drug yet

brand
Oxlumo
generic
lumasiran
indication
Primary Hyperoxaluria Type I
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 9m ago
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