small molecule

FILSUVEZ

BIRCH TRITERPENES

Loss of exclusivityJanuary 2039latest FDA-listed patent expiry
CompanyCHIESI FARMACEUTICI SPA

Drug detail

Brand nameFILSUVEZ
Active ingredientBIRCH TRITERPENES
Strength10%
Dosage formGEL
RouteTOPICAL
ModalitySmall molecule
FDA approvalDecember 2023
Marketing statusRX

Listed patents

PatentExpiresType
11266660January 2039use U-3811
12268695January 2039use U-3811
11083733January 2039product
9827214November 2030use U-3811
9352041November 2030use U-3811
8828444June 2026product

Regulatory exclusivity

CodeExpires
ODE-460December 2030
NCEDecember 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

FILSUVEZ patent cliff — loss of exclusivity January 2039 | CliffBio