Apalutamide manufacturers

About apalutamide

Apalutamide manufacturers include the originator Janssen (Johnson & Johnson), which sells Erleada, and generic developers such as Zydus, which received US approval for 60 mg tablets in March 2025. Apalutamide is an oral androgen receptor inhibitor for prostate cancer. It is approved for non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. Pharmaceutical companies can source apalutamide tablets and API through out-licensing, supply or technology transfer, subject to patent status. Dossiers are being developed in US ANDA and EU CTD formats.

Apalutamide key facts

Apalutamide manufacturers and licensing history

Apalutamide was discovered by Aragon Pharmaceuticals, based on research at the University of California, and developed as ARN-509. Johnson & Johnson acquired Aragon in 2013, and Janssen now markets apalutamide as Erleada.

The FDA approved Erleada on 14 February 2018 for nmCRPC, based on the SPARTAN trial. Approval for mCSPC followed in 2019. A single 240 mg tablet was approved in the US on 17 February 2023. The EU approved Erleada on 14 January 2019.

Five generic companies filed ANDAs with paragraph IV patent challenges for the 60 mg tablet from February 2022. The FDA approved Zydus's 60 mg tablets on 17 March 2025, but launch depends on patent outcomes. Buyers should confirm the API's crystal form, GMP status and freedom to operate before choosing a dossier partner.

Apalutamide dosage forms and dossier types

Apalutamide is approved as 60 mg tablets and, in the US, as a 240 mg tablet. Generic apalutamide manufacturers develop 60 mg tablets first, because this is the main reference strength.

Apalutamide regulatory and patent status

The FDA approved Erleada on 14 February 2018, and the EU on 14 January 2019. In the US, several generic companies have challenged its patents, and the FDA approved Zydus's 60 mg tablets in March 2025. Erleada is protected by compound, formulation and use patents and, in the EU, by supplementary protection certificates. Check the FDA Orange Book, litigation status and national SPC registers before planning a launch.

Apalutamide mechanism of action and therapeutic use

Apalutamide binds to the androgen receptor and blocks testosterone signalling. It also stops the receptor from moving into the cell nucleus and switching on genes that drive prostate cancer growth. Apalutamide is used with androgen deprivation therapy for nmCRPC and mCSPC, at 240 mg once daily.

Apalutamide licensing and sourcing

Apalutamide suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier readiness, patent position and territory availability. Current offers and supplier contacts are listed among the apalutamide manufacturers on Pipelinepharma.

Frequently asked questions about apalutamide

Who are the main apalutamide manufacturers? Janssen, part of Johnson & Johnson, makes Erleada. Generic developers include Zydus, which received US approval for 60 mg tablets in March 2025.

Is there a generic version of apalutamide? The FDA approved Zydus's generic 60 mg tablets in March 2025, but launch depends on patent litigation. Several other companies have filed ANDAs.

Is an apalutamide dossier available for licensing? Apalutamide 60 mg tablet dossiers are being developed in US ANDA and EU CTD formats. Buyers should check patent and SPC status in each target country.

What forms and strengths of apalutamide are available? Apalutamide is available as 60 mg tablets, with a 240 mg single tablet in the US.

When was apalutamide first approved? The US FDA approved apalutamide on 14 February 2018, and the EU on 14 January 2019.