drug

birch triterpenes

Marketedupdated 2mo ago

by Chiesi USA Inc

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Dec 18, 2028

~2.5 years out

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

patents (6)

Jan 4, 2039formulationUS 11083733
Jan 4, 2039method-of-use (U-3811)US 11266660
Jan 4, 2039method-of-use (U-3811)US 12268695
Nov 24, 2030method-of-use (U-3811)US 93520414.4y
Nov 24, 2030method-of-use (U-3811)US 98272144.4y
Jun 21, 2026formulationUS 8828444

FDA exclusivities (2)

Dec 18, 2030ODE-460Orphan Drug (7y)4.5y
Dec 18, 2028NCENew Chemical Entity (5y)2.5y

Data sources

ClinicalTrials.gov

last refreshed 1h ago

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Trials studying birch triterpenes

—A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvezrecruitingn=580