drug

lomitapide

Marketedupdated 2mo ago

by Chiesi USA Inc

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Aug 19, 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 (12)

Jul 29, 2041method-of-use (U-4438)US 12472172
Jul 29, 2041method-of-use (U-4438)US 12472172
Jul 29, 2041method-of-use (U-4438)US 12472172
Jul 29, 2041method-of-use (U-4438)US 12472172
Jul 29, 2041method-of-use (U-4438)US 12472172
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y
Aug 19, 2027method-of-use (U-1316)US 79322681.1y

Data sources

ClinicalTrials.gov

last refreshed 2h ago

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Trials studying lomitapide

phase3Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)completedn=46
—LOWER: Lomitapide Observational Worldwide Evaluation Registryrecruitingn=300