Alectinib manufacturers

About alectinib

Alectinib manufacturers include the originator Chugai Pharmaceutical, part of the Roche group, which sells Alecensa worldwide with Roche and Genentech. Alectinib is an oral anaplastic lymphoma kinase (ALK) inhibitor for ALK-positive non-small cell lung cancer (NSCLC), including adjuvant treatment after surgery. Pharmaceutical companies can source alectinib capsules and API through out-licensing, supply or technology transfer for markets where patents allow. Dossiers are being developed in CTD and ANDA formats ahead of patent expiry.

Alectinib key facts

Alectinib manufacturers and licensing history

Chugai Pharmaceutical discovered alectinib. Japan was the first country to approve it, on 4 July 2014, for advanced ALK-positive NSCLC. Roche, Chugai's majority owner, sells Alecensa outside Japan, and Genentech markets it in the US.

The FDA granted accelerated approval on 11 December 2015 for patients who had progressed on crizotinib. Full approval for first-line use followed on 6 November 2017, based on the ALEX trial. On 18 April 2024, the FDA approved alectinib as the first adjuvant treatment for resected ALK-positive NSCLC, based on the ALINA trial.

No generic alectinib is approved in the US. Generic developers are preparing API and capsule dossiers for launch after patent expiry. Buyers should confirm the API's polymorphic form, GMP status and freedom to operate before choosing a dossier partner.

Alectinib dosage forms and dossier types

Alectinib is approved as 150 mg hard capsules in the US and EU. Generic alectinib manufacturers develop 150 mg capsules, because Alecensa 150 mg is the reference product.

Alectinib regulatory and patent status

Japan approved alectinib on 4 July 2014. The FDA approved it on 11 December 2015, and the EU granted conditional approval in February 2017. Adjuvant use was approved in the US in April 2024 and the EU in June 2024.

Patents listed for Alecensa in the US expire between 2030 and 2035, covering the compound, compositions and high-dose formulations. Check the FDA Orange Book and national patent registers before planning a launch.

Alectinib mechanism of action and therapeutic use

Alectinib blocks the ALK tyrosine kinase, which drives tumour growth in ALK-positive cancers. It also inhibits RET kinase and reaches the brain, which helps control brain metastases. Alectinib is used for ALK-positive NSCLC, both as first-line treatment of advanced disease and as adjuvant treatment after surgery. An FDA-approved test is needed to confirm ALK status.

Alectinib licensing and sourcing

Alectinib 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 format and readiness, patent position and territory availability. Current offers and supplier contacts are listed among the alectinib manufacturers on Pipelinepharma.

Frequently asked questions about alectinib

Who are the main alectinib manufacturers? Chugai Pharmaceutical discovered alectinib and sells it as Alecensa with Roche and Genentech. Generic developers are preparing API and capsule dossiers for markets where patents have expired or do not apply.

Is there a generic version of alectinib? No generic alectinib is approved in the US. Listed US patents run to 2030–2035, so generic entry depends on patent expiry or challenges.

Is an alectinib dossier available for licensing? Alectinib capsule dossiers are being developed in CTD and ANDA formats. Buyers should check the patent and SPC position in each target country before filing.

What forms and strengths of alectinib are available? Alectinib is available as 150 mg hard capsules in the US and EU. Japan also has lower strengths.

When was alectinib first approved? Japan approved alectinib on 4 July 2014, the US on 11 December 2015 and the EU in February 2017.