Aethacizinum manufacturers

About aethacizinum

Aethacizinum manufacturers include the originator Olainfarm of Latvia, which sells Etacizin, and Optimus Pharma of India, which supplies Etacunorm to Russia. Aethacizinum (ethacizine) is a class IC antiarrhythmic drug related to moracizine. It was developed in the USSR and is used in Russia, Latvia and other CIS countries for atrial fibrillation, tachycardia and extrasystoles. Pharmaceutical companies can source aethacizinum 50 mg tablets through out-licensing, supply or technology transfer.

Aethacizinum key facts

Aethacizinum manufacturers and licensing history

Aethacizinum was developed in the USSR by researchers at the Institute of Pharmacology of the Academy of Medical Sciences, led by E.I. Chazov. Patents were filed in Sweden, France and the UK in 1984. It is chemically related to moracizine, another Soviet-developed antiarrhythmic.

Olainfarm of Latvia manufactures and sells aethacizinum as Etacizin 50 mg coated tablets. The Russian registration was issued on 7 October 2008 and re-issued on 17 February 2020. Etacizin is also marketed in Latvia, Lithuania, Kyrgyzstan, Mongolia and other markets.

In April 2023, Optimus Pharma of India registered the first generic, Etacunorm 50 mg tablets, in Russia. Buyers should confirm GMP status, EAEU registration status and API source before choosing a dossier partner.

Aethacizinum dosage forms and dossier types

Aethacizinum is approved as 50 mg film-coated tablets. Generic aethacizinum manufacturers develop 50 mg tablets, because Etacizin is the only reference product.

Aethacizinum regulatory and patent status

Aethacizinum is off-patent, with original patents dating from 1984. Etacizin holds registrations in Russia, Latvia and several CIS and Asian markets. Its Latvian SmPC is held by the State Agency of Medicines (ZVA). Optimus Pharma’s Etacunorm became the first registered generic in Russia in April 2023. Aethacizinum is not approved in the US or Western EU.

Aethacizinum mechanism of action and therapeutic use

Aethacizinum blocks fast sodium channels in heart cell membranes, which slows conduction and stabilises the heart rhythm. To a lesser extent, it also blocks slow calcium channels. It has anticholinergic and local anaesthetic effects. It is used for supraventricular and ventricular extrasystoles, tachycardia, atrial flutter and atrial fibrillation in adults. It is not approved for patients under 18.

Aethacizinum licensing and sourcing

Aethacizinum suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, EAEU GMP), dossier format and readiness, API source and territory availability. Current offers and supplier contacts are listed among the aethacizinum manufacturers on Pipelinepharma.

Frequently asked questions about aethacizinum

Who are the main aethacizinum manufacturers?
Olainfarm of Latvia is the main manufacturer and sells aethacizinum as Etacizin. Optimus Pharma of India registered the first generic, Etacunorm, in Russia in April 2023.

What is the difference between aethacizinum and ethacizine?
They are the same drug. Aethacizinum is the Latin name used on Olainfarm’s labels, and ethacizine (or ethacyzine) is the English name.

Is there a generic version of aethacizinum?
Yes. Optimus Pharma’s Etacunorm 50 mg tablets were registered in Russia on 10 April 2023, as the first generic of Etacizin.

Is aethacizinum approved in the EU or US?
Aethacizinum is not approved in the US. In the EU, Etacizin is registered nationally in Latvia and marketed in Lithuania, but it is not authorised in Western EU countries.

What forms and strengths of aethacizinum are available?
Aethacizinum is available as 50 mg film-coated tablets. This is the only marketed strength