Dosing Regimens Associated With Extended Release Paliperidone Injectable Formulations

Patent No. EP4025187 (titled "Dosing Regimens Associated With Extended Release Paliperidone Injectable Formulations") was filed by Janssen Pharmaceutica on May 7, 2021. The application was issued on Jan 3, 2024.

Patent Summary

Paliperidone palmitate for treating psychosis, schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar disorder, comprising administering a second dose of the paliperidone palmitate extended-release injectable suspension to a deltoid or gluteal muscle of the patient up to two weeks before or three weeks after a time that is six months after administration of the first dose, without an intervening dose of paliperidone palmitate between the first dose and the second dose, wherein the paliperidone palmitate extended-release injectable suspension comprises about 312 mg/mL of paliperidone palmitate, wherein the paliperidone palmitate extended-release injectable suspension is an aqueous composition which further comprises a suspending agent, a buffer, and optionally one or more of a preservative and an isotonizing agent, wherein the first dose comprises about 1092 mg of paliperidone palmitate or about 1560 mg of paliperidone palmitate; and wherein the second dose comprises about 1092 mg of paliperidone palmitate or about 1560 mg of paliperidone palmitate.

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Patent Family

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
HAMM & WITTKOPPOct 4, 2024HAMM & WITTKOPP
GENERICS UKOct 3, 2024ELKINGTON AND FIFE

Dossier Documents

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EP4025187

JANSSEN PHARMACEUTICA
Application Number
EP21724651A
Filing Date
May 7, 2021
Status
Granted And Under Opposition
Dec 1, 2023
Publication Date
Jan 3, 2024