Dosing Regimens Associated With Extended Release Paliperidone Injectable Formulations A Schedule for Long-Acting Antipsychotic Injections

This patent describes specific dosing regimens for treating patients with long-acting injectable formulations of paliperidone palmitate, a slow-release form of an antipsychotic medicine. Rather than a new molecule, the invention is a carefully worked out schedule of doses and timing intended to keep patients within an effective and safe range over weeks or months.

The Problem

Schizophrenia and related psychiatric conditions are often managed with daily oral medication, but many patients struggle to take a tablet every day. Missed doses are one of the most common reasons that symptoms return. Long-acting injectable medicines address this by releasing the drug slowly from a single injection given every few weeks or months, so steady protection no longer depends on daily routine. The challenge is designing the dosing schedule. Doses that are too high risk side effects, doses too low risk relapse, and the slow-release nature of the formulation makes the early weeks after starting or switching treatment particularly tricky to get right.

What This Invention Does

The patent sets out methods of treating patients using extended-release paliperidone palmitate, defining the loading doses, maintenance doses, injection sites and timing intervals that keep the medicine within the desired therapeutic window. The regimens cover how to start treatment, how to maintain it over the long term, and how to handle special situations such as a missed dose or adjustments for particular patient groups. By claiming the regimen itself, the patent protects the practical knowledge of how to use the formulation well, not just the drug substance.

Key Features

• Defined loading and maintenance doses. The schedule specifies initiation doses followed by maintenance doses at set intervals.
• Injection timing and intervals. The regimens lay out how many days or weeks should separate each injection.
• Missed-dose handling. The methods address what to do when an injection is delayed, a common real-world problem.
• Patient-group tailoring. Adjustments are described for relevant patient populations and clinical circumstances.
• Built on an approved active. The regimens use paliperidone palmitate, a well-established slow-release antipsychotic.

Who Is Behind It

The applicant is Janssen Pharmaceutica NV, the Belgium-based pharmaceutical arm long associated with central nervous system medicines and part of the wider Johnson & Johnson group. The named inventors are Srihari Gopal, Raja Venkatasubramanian and Huybrecht T’Jollyn. The application is a divisional that traces back through earlier Australian filings to a priority application first filed in late 2020.

Why It Matters

Treatment adherence is one of the strongest predictors of good outcomes in serious mental illness, and long-acting injectables are a key tool for improving it. A protected, well-specified dosing regimen gives clinicians a clear protocol and gives the manufacturer a defensible position around how its formulation is used in practice. Holding the rights in Australia matters wherever the product is prescribed and supplied across the local mental health system.

Related Concepts

• Paliperidone – the active antipsychotic compound at the centre of the formulation.
• Depot injection – the slow-release injectable delivery approach used here.
• Schizophrenia – a principal condition the regimens are designed to treat.
• Adherence in medicine) – the real-world problem long-acting injectables aim to solve.
• Atypical antipsychotic – the drug class paliperidone belongs to.

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AU 2026201895 was published in the Australian Official Journal of Patents on 2 April 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.