Acotiamide manufacturers

About acotiamide

Acotiamide manufacturers include the originator Zeria Pharmaceutical (Acofide, Japan), Indian companies such as Lupin, Torrent, Sun Pharma and Alembic, and several Chinese generic producers. Acotiamide hydrochloride hydrate is a first-in-class prokinetic agent for functional dyspepsia. It works by inhibiting peripheral acetylcholinesterase. Pharmaceutical companies can source acotiamide 100 mg tablets and 300 mg extended-release tablets through out-licensing, supply or technology transfer. Dossiers are available in Indian, Chinese and CTD formats.

Acotiamide key facts

Acotiamide manufacturers and licensing history

Acotiamide was discovered by Zeria Pharmaceutical and co-developed with Astellas under a 2008 agreement. Zeria filed in Japan in September 2010 and received approval for Acofide 100 mg tablets on 25 March 2013. It was the world’s first treatment approved for functional dyspepsia diagnosed by Rome III criteria.

In India, Lupin received CDSCO approval for acotiamide 100 mg tablets in August 2016. Torrent (Dycotiam), Alembic (Tocamide) and many other companies followed. Sun Pharma also markets 300 mg extended-release tablets (Actapro OD).

In China, acotiamide entered the market in 2020, and several domestic companies now hold tablet approvals. More than 10 acotiamide API registrations are listed on China’s CDE platform. Buyers should confirm GMP status, the CDE registration status and a DMF before choosing a dossier partner.

Acotiamide dosage forms and dossier types

Acotiamide is approved as 100 mg film-coated tablets, and India also has 300 mg extended-release tablets. Generic acotiamide manufacturers most often develop 100 mg tablets, because Acofide 100 mg is the reference product.

Acotiamide regulatory and patent status

Japan’s MHLW approved Acofide 100 mg tablets on 25 March 2013, after a filing in September 2010. NHI price listing followed on 24 May 2013, and launch on 6 June 2013. Phase II trials were completed in the US and Europe, but acotiamide has not been approved in either region.

India’s CDSCO approved acotiamide 100 mg tablets for Lupin in August 2016. China approved acotiamide in 2020. The core compound patent expired in Japan in 2022 and in China in 2023, opening both markets to generics. Confirm formulation and process patents in each target country before filing.

Acotiamide mechanism of action and therapeutic use

Acotiamide inhibits peripheral acetylcholinesterase, which raises acetylcholine levels in the gut wall. This improves impaired gastric motility and delayed gastric emptying. Unlike older prokinetics, acotiamide has little or no affinity for serotonin or dopamine D2 receptors. It is approved for postprandial fullness, upper abdominal bloating and early satiation due to functional dyspepsia.

Acotiamide licensing and sourcing

Acotiamide 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, API source and territory availability. Current offers and supplier contacts are listed among the acotiamide manufacturers on Pipelinepharma.

Frequently asked questions about acotiamide

Who are the main acotiamide manufacturers?
Zeria Pharmaceutical is the originator and sells Acofide in Japan. In India, Lupin, Torrent, Sun Pharma, Alembic and many others market acotiamide tablets. Several Chinese companies have held approvals since the drug entered China in 2020.

Which countries produce acotiamide API and finished dosage forms?
Acotiamide API and finished products come mainly from Japan, India and China. China has more than 10 API registrations at CDE. Buyers should ask suppliers for GMP certificates and DMF documentation.

Is an acotiamide CTD dossier available for licensing?
Yes. Acotiamide 100 mg tablet dossiers are offered for licensing in CTD-based formats for China, India and export markets. An EU CTD dossier has no reference product, because acotiamide is not approved in the EU.

When did the acotiamide patent expire?
The core compound patent expired in Japan in 2022 and in China in 2023. Generic acotiamide has been marketed in India since 2016. Check national registers for formulation patents before filing.

What forms and strengths of acotiamide are available?
Acotiamide is available as 100 mg film-coated tablets in Japan, India and China. India also has 300 mg extended-release tablets for once-daily dosing.