drug

viltolarsen

Marketedupdated 2mo ago

by NS Pharma Inc

Approved

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indications

investigational

Duchenne Muscular Dystrophy

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Patent cliff

source: FDA Orange Book

first barrier falls

Aug 12, 2027

~1.1 years out

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

patents (2)

Apr 3, 2034compositionUS 9079934
Aug 31, 2031compositionUS 10870676

FDA exclusivities (1)

Aug 12, 2027ODE-280Orphan Drug (7y)1.1y

Data sources

ClinicalTrials.gov

last refreshed 49m ago

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Trials studying viltolarsen

phase3Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)completedn=77
phase2Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)completedn=20
phase3Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)unknownn=74