drug

fexinidazole

Marketedupdated 2mo ago

by Sanofi-Aventis US LLC

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Jul 16, 2026

9 days

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

FDA exclusivities (2)

Jul 16, 2028ODE-359Orphan Drug (7y)2.0y
Jul 16, 2026NCENew Chemical Entity (5y)9d

Data sources

ClinicalTrials.gov

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Trials studying fexinidazole

phase1A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairmentcompletedn=21
phase3Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stagecompletedn=174