drug

linerixibat

Marketedupdated 2mo ago

by GlaxoSmithKline LLC

Approved

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all catalysts(1)

approval · 1

Mar 17, 2026

approval

4mo ago

LYNAVOY (LINERIXIBAT) — FDA approval

linerixibat

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Patent cliff

source: FDA Orange Book

first barrier falls

Sep 6, 2031

~5.2 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)

Sep 6, 2031compositionUS 9040518

Data sources

openFDA · ClinicalTrials.gov

last refreshed 31m ago

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top 3

Trials studying linerixibat

phase3Linerixibat Long-term Safety, and Tolerability Studyactive not recruitingn=242
phase3Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)completedn=238
—Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)available