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  1. pharmadog
  2. ›drugs
  3. ›Radicava ORS
drug
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edaravone

Marketedupdated 3mo ago
by $SGIOF SHIONOGI & CO LTD
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for axial length measurement and amyotrophic lateral sclerosis and 6 investigational indications.

indications

investigational
ALS

all catalysts(0)

nothing on the calendar yet

Trials studying edaravone

  • phase2Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASILnot yet recruitingn=60
  • phase1Bioequivalence of TTYP01 Tablets in Healthy Adult Subjectscompletedn=29
  • phase4Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Strokecompletedn=401
  • phase2Study of Compound Edaravone Injection for Treatment of Acute Ischemic Strokesuspendedn=240
  • —Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)unknownn=300
  • phase3Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Strokeunknownn=212

Patent cliff

source: FDA Orange Book
first barrier falls
May 12, 2029
~2.8 years out

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

patents (11)

  • Nov 12, 2041method-of-use (U-4111)US 12194025
  • Nov 12, 2041method-of-use (U-4111)US 12310946
  • Nov 12, 2041method-of-use (U-4111)US 12478611
  • Nov 12, 2041method-of-use (U-4111)US 12527769
  • Nov 12, 2041method-of-use (U-4111)US 12569469
  • Nov 1, 2039formulationUS 10987341
  • Nov 1, 2039formulationUS 11241416
  • Nov 1, 2039method-of-use (U-3468)US 11478450
  • Nov 1, 2039formulationUS 11826352
  • Nov 1, 2039formulationUS 11957660
  • Nov 1, 2039formulationUS 12285409

FDA exclusivities (1)

  • May 12, 2029ODE-144Orphan Drug (7y)2.8y

News(0)

no news has mentioned this drug yet

brand
Radicava ORS
generic
edaravone
indication
Amyotrophic Lateral Sclerosis
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 9m ago
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