Paliperidone palmitate – USA

On Apr. 01, 2024, Federal Circuit affirmed affirmed district court’s indefiniteness determination but vacated and remanded its nonobviousness determination.


Janssen markets and sells INVEGA SUSTENNA which is an extended-release intramuscular injectable of paliperidone palmitate, indicated for the treatment of schizophrenia in adults. Teva filed ANDA challenging validity of US 9,439,906. The 906 patent relates to dosing regimens, specifically first loading dose of about 150 mg-eq. of
paliperidone in deltoid muscle, a second loading dose …

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