Cariprazine manufacturers

About cariprazine

Cariprazine manufacturers include the originator Gedeon Richter of Hungary and AbbVie, which sells it as Vraylar in the US, while generic companies such as Zydus and Sun Pharma hold US approvals awaiting patent expiry. Cariprazine is an oral atypical antipsychotic that acts as a dopamine D3-preferring D3/D2 partial agonist. It is used for schizophrenia, bipolar I disorder and, in the US, as an add-on treatment for major depression. Pharmaceutical companies can source cariprazine capsules and API through out-licensing, supply or technology transfer.

Cariprazine key facts

Cariprazine manufacturers and licensing history

Gedeon Richter discovered cariprazine and developed it in the US with Forest Laboratories, later Allergan and now AbbVie. The FDA approved Vraylar on 17 September 2015 for schizophrenia and bipolar mania. Approvals followed for bipolar depression and, in 2022, as an add-on treatment for major depression. In Europe, Gedeon Richter sells it as Reagila, approved in 2017 for schizophrenia.

In the US, generic companies filed ANDAs from 2019. Zydus and Sun Pharma received approvals in September 2022, but cannot launch until the patents expire. Listed compound and formulation patents run to 2029 and 2030, including paediatric exclusivity. In 2025, AbbVie and Gedeon Richter sued Deva over another ANDA.

Buyers should confirm the API crystal form, formulation stability (cariprazine is sensitive to hydrolysis), GMP status and freedom to operate before choosing a dossier partner.

Cariprazine dosage forms and dossier types

Cariprazine is approved as 1.5, 3, 4.5 and 6 mg capsules. Generic manufacturers develop all four strengths.

Cariprazine regulatory and patent status

The FDA approved cariprazine on 17 September 2015, and the EU in 2017. Generic versions from Zydus and Sun Pharma were approved in the US in 2022, but launch depends on patents that run to 2029–2030 with paediatric exclusivity. Litigation continues against other generic filers. Check the FDA Orange Book and national registers before planning a launch.

Cariprazine mechanism of action and therapeutic use

Cariprazine is a partial agonist at dopamine D3 and D2 receptors, with a preference for D3, and at serotonin 5-HT1A receptors. It also blocks 5-HT2A receptors. This profile may help with negative symptoms of schizophrenia and with mood. Cariprazine is taken once daily for schizophrenia, bipolar I disorder and, in the US, as an add-on treatment for major depression.

Cariprazine licensing and sourcing

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

Frequently asked questions about cariprazine

Who are the main cariprazine manufacturers? Gedeon Richter is the originator and sells Reagila. AbbVie sells Vraylar in the US. Zydus and Sun Pharma hold US generic approvals.

When can generic cariprazine launch in the US? US generics are approved but cannot launch until patents expire, which is expected in 2029–2030 including paediatric exclusivity.

What forms and strengths of cariprazine are available? Cariprazine is available as 1.5, 3, 4.5 and 6 mg capsules.

What is cariprazine used for? Cariprazine is used for schizophrenia and bipolar I disorder, and in the US as an add-on treatment for major depression.

What is the difference between Vraylar and Reagila? They contain the same drug. Vraylar is AbbVie's US brand, and Reagila is Gedeon Richter's brand in Europe and other markets.