Fenfluramine Compositions And Methods Of Preparing The Same

Patent No. EP3800177 (titled "Fenfluramine Compositions And Methods Of Preparing The Same") was filed by Zogenix on Dec 20, 2016. The application was issued on Jan 29, 2025.

Patent Summary

A method for preparing fenfluramine active pharmaceutical ingredient (API) with reduced levels of impurities, particularly trifluoromethyl regioisomers. The method involves hydrolyzing 2-(3-(trifluoromethyl)phenyl)acetonitrile to produce 2-(3-(trifluoromethyl)phenyl)acetic acid, reacting the acid with acetic anhydride to form 1-(3-(trifluoromethyl)phenyl)propan-2-one, and reductively aminating the ketone with ethylamine to produce fenfluramine. The resulting API has a purity profile of at least 90% fenfluramine, less than 0.2% 2-fenfluramine, less than 0.2% 4-fenfluramine, and less than 1% fenfluramine alcohol.

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Patent Oppositions (2)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentative
ALFRED E TIEFENBACHEROct 29, 2025HAMM & WITTKOPP
SANDOZOct 23, 2025KRAUS & LEDERER PARTGMBB

Dossier Documents

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EP3800177

ZOGENIX
Application Number
EP20210227A
Filing Date
Dec 20, 2016
Status
Granted And Under Opposition
Dec 26, 2024
Publication Date
Jan 29, 2025