Valbenazine manufacturers

About valbenazine

Valbenazine manufacturers are currently limited to the originator, Neurocrine Biosciences, which sells it as Ingrezza in the US, and Mitsubishi Tanabe in Japan. Valbenazine is an oral vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia and chorea in Huntington's disease. Under settlements, four generic companies may launch in the US from 1 March 2038. Pharmaceutical companies can prepare valbenazine capsule and API dossiers for markets where patents allow.

Valbenazine key facts

Valbenazine manufacturers and licensing history

Neurocrine Biosciences developed valbenazine, and the FDA approved Ingrezza in April 2017 as the first treatment for tardive dyskinesia, a movement disorder caused by long-term antipsychotic use. In August 2023, the FDA approved it for chorea in Huntington's disease. A sprinkle formulation for patients who have trouble swallowing followed. Mitsubishi Tanabe markets valbenazine in Japan.

Ingrezza has become Neurocrine's main product. Several generic companies filed ANDAs challenging its patents. In November 2023, Neurocrine settled all litigation, and four companies may launch generic valbenazine in the US from 1 March 2038, or earlier in certain circumstances.

Buyers should confirm the API salt and crystal form, GMP status and freedom to operate before choosing a dossier partner.

Valbenazine dosage forms and dossier types

Valbenazine is approved as 40, 60 and 80 mg capsules and as sprinkle capsules.

Valbenazine regulatory and patent status

The FDA approved valbenazine in April 2017 for tardive dyskinesia and in August 2023 for Huntington's chorea. Under November 2023 settlements, four generic companies may launch in the US from 1 March 2038. Valbenazine is also approved in Japan but not in the EU. Check national patents before development in other markets.

Valbenazine mechanism of action and therapeutic use

Valbenazine blocks VMAT2, the protein that packs dopamine into storage vesicles in nerve cells. This reduces dopamine release and calms the involuntary movements of tardive dyskinesia and Huntington's chorea. It is taken once daily as a capsule.

Valbenazine licensing and sourcing

Valbenazine is currently available only from Neurocrine and its Japanese partner. Companies interested in this molecule usually prepare future generic dossiers or API supply. Current offers and supplier contacts are listed among the valbenazine manufacturers on Pipelinepharma.

Frequently asked questions about valbenazine

Who manufactures valbenazine? Neurocrine Biosciences makes valbenazine and sells it as Ingrezza in the US. Mitsubishi Tanabe markets it in Japan.

When can generic valbenazine launch in the US? Under November 2023 settlements, four generic companies may launch from 1 March 2038, or earlier in certain circumstances.

What is valbenazine used for? Valbenazine is used for tardive dyskinesia in adults and chorea associated with Huntington's disease.

What forms and strengths of valbenazine are available? Valbenazine is available as 40, 60 and 80 mg capsules and as sprinkle capsules.

Is valbenazine approved in the EU? No. Valbenazine is approved in the US and Japan but not in the EU.