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

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openFDA · ClinicalTrials.gov

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linerixibat

Marketedupdated 3mo ago

by GlaxoSmithKline LLC

Approved

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🐶 often sniffed alongside

top 3

all catalysts(1)

approval · 1

Mar 17, 2026

approval

5mo ago

LYNAVOY (LINERIXIBAT) — FDA approval

linerixibat

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Trials studying linerixibat

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

Patent cliff

source: FDA Orange Book

first barrier falls

Sep 6, 2031

~5.0 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

News(0)

no news has mentioned this drug yet

Data sources

openFDA · ClinicalTrials.gov

last refreshed 10m ago

Found something off?

comments(0)

5-min edit window · permanent after that

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linerixibat

🐶 often sniffed alongside

all catalysts(1)

Trials studying linerixibat

Patent cliff

patents (1)

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linerixibat

🐶 often sniffed alongside

all catalysts(1)

Trials studying linerixibat

Patent cliff

patents (1)

News(0)

Report a data issue

comments(0)