Amifostine manufacturers

About amifostine

Amifostine manufacturers include Legacy Pharma, which now holds Ethyol in the US, and generic makers such as Sun Pharma and Eugia. Amifostine is a cytoprotective prodrug that protects normal tissues from damage by chemotherapy and radiation. It reduces kidney toxicity from cisplatin and dry mouth (xerostomia) from head and neck radiotherapy. Pharmaceutical companies can source amifostine 500 mg lyophilised powder for injection through out-licensing, supply or technology transfer.

Amifostine key facts

Amifostine manufacturers and licensing history

Amifostine was first developed in the US Army's Cold War radiation-protection programme. U.S. Bioscience developed it as Ethyol. The FDA approved it on 8 December 1995 to reduce cumulative kidney toxicity from cisplatin, after earlier advisory panels had asked for more data.

In 1999, the FDA approved a second use: reducing dry mouth in patients receiving radiotherapy for head and neck cancer. Ethyol passed through MedImmune and AstraZeneca and is now held by Legacy Pharma in the US.

Sun Pharma received a US generic approval in 2008 and Eugia in 2017, but both are now listed as discontinued. This leaves Ethyol as the main product in the US. Buyers should confirm GMP status, sterile lyophilisation capability and a DMF before choosing a dossier partner.

Amifostine dosage forms and dossier types

Amifostine is approved as a 500 mg lyophilised powder for intravenous infusion. Generic amifostine manufacturers develop the same vial, referencing Ethyol.

Amifostine regulatory and patent status

The FDA approved Ethyol on 8 December 1995 for cisplatin kidney toxicity and in 1999 for radiation-induced xerostomia. It is also approved in Europe for similar uses. Patents have expired. US generics were approved in 2008 and 2017 but are now discontinued, so supply depends mainly on the brand.

Amifostine mechanism of action and therapeutic use

Amifostine is a prodrug. Alkaline phosphatase, which is more active in normal tissue than in tumours, converts it to an active thiol. This thiol neutralises free radicals and binds toxic drug metabolites, protecting normal cells. Amifostine is given by infusion before cisplatin or radiotherapy. Common side effects are low blood pressure, nausea and vomiting.

Amifostine licensing and sourcing

Amifostine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA), sterile manufacturing capability, dossier format and territory availability. Current offers and supplier contacts are listed among the amifostine manufacturers on Pipelinepharma.

Frequently asked questions about amifostine

Who are the main amifostine manufacturers? Legacy Pharma holds Ethyol in the US. Sun Pharma and Eugia have held US generic approvals, but both are now discontinued.

Is there a generic version of amifostine? US generics were approved in 2008 and 2017, but both are listed as discontinued. This creates an opportunity for new generic suppliers.

Is an amifostine dossier available for licensing? Amifostine 500 mg dossiers can be licensed in US ANDA and CTD formats, referencing Ethyol. Sterile lyophilisation is required.

What forms and strengths of amifostine are available? Amifostine is available as a 500 mg lyophilised powder in single-dose vials, for intravenous infusion.

What is amifostine used for? Amifostine reduces kidney toxicity from cisplatin in ovarian cancer and reduces dry mouth from radiotherapy for head and neck cancer.