Paliperidone palmitate manufacturers

About paliperidone palmitate

Paliperidone palmitate manufacturers are led by the originator, Janssen (Johnson & Johnson), which sells monthly, 3-monthly and 6-monthly long-acting injections, while generic developers such as Teva have US approval but cannot launch until 2031. Paliperidone palmitate is a long-acting injectable form of the antipsychotic paliperidone, used for schizophrenia and schizoaffective disorder. Pharmaceutical companies can source paliperidone palmitate injection and API through out-licensing, supply or technology transfer for markets where patents allow.

Paliperidone palmitate key facts

Paliperidone palmitate manufacturers and licensing history

Janssen developed paliperidone palmitate as a long-acting injection of paliperidone, the active metabolite of risperidone. The FDA approved the 1-month Invega Sustenna on 31 July 2009. A 3-month version, Invega Trinza, followed in 2015, and a 6-month version, Invega Hafyera, in 2021. In Europe, they are sold as Xeplion, Trevicta and Byannli.

Teva received FDA approval for a generic of Invega Sustenna on 6 July 2021, and other companies, including Tolmar and Accord, filed ANDAs. Janssen sued, and courts upheld its dosing-regimen patent, which blocks US generic approval until 26 January 2031.

Long-acting injectables need specialised nanoparticle suspension manufacturing. Buyers should confirm particle size control, sterile manufacturing capability, GMP status and freedom to operate before choosing a dossier partner.

Paliperidone palmitate dosage forms and dossier types

Paliperidone palmitate is supplied as extended-release injectable suspensions in prefilled syringes, for monthly, 3-monthly or 6-monthly dosing.

Paliperidone palmitate regulatory and patent status

The FDA approved Invega Sustenna on 31 July 2009, Invega Trinza in 2015 and Invega Hafyera in 2021. Teva's generic was approved in July 2021, but US courts upheld Janssen's dosing-regimen patent, so generic approvals cannot take effect before 26 January 2031. Check the FDA Orange Book and national registers before planning a launch.

Paliperidone palmitate mechanism of action and therapeutic use

Paliperidone blocks dopamine D2 and serotonin 5-HT2A receptors in the brain, which reduces symptoms of psychosis. The palmitate ester dissolves slowly from the injection site, releasing paliperidone over one, three or six months. Paliperidone palmitate is used for schizophrenia in adults and, as the 1-month injection in the US, for schizoaffective disorder. Long intervals between injections help patients stay on treatment.

Paliperidone palmitate licensing and sourcing

Paliperidone palmitate suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status, LAI manufacturing capability, patent position and territory availability. Current offers and supplier contacts are listed among the paliperidone palmitate manufacturers on Pipelinepharma.

Frequently asked questions about paliperidone palmitate

Who are the main paliperidone palmitate manufacturers? Janssen is the originator and sells Invega Sustenna, Trinza and Hafyera (Xeplion, Trevicta and Byannli in Europe). Teva has a US generic approval but cannot launch before 2031.

When can generic paliperidone palmitate launch in the US? US courts upheld Janssen's dosing-regimen patent, so generic approvals cannot take effect before 26 January 2031.

What forms and strengths of paliperidone palmitate are available? Paliperidone palmitate is available as 1-month (39–234 mg), 3-month (273–819 mg) and 6-month (1,092 and 1,560 mg) injections.

What is the difference between paliperidone and paliperidone palmitate? Paliperidone is the active drug, taken as a daily tablet. Paliperidone palmitate is an ester that releases paliperidone slowly after injection.

What is paliperidone palmitate used for? Paliperidone palmitate is used for schizophrenia in adults and, in the US, for schizoaffective disorder.