Alclometasone manufacturers

About alclometasone

Alclometasone manufacturers include Fougera, which holds the original Aclovate applications, and US generic makers such as Taro. Alclometasone dipropionate is a low-to-medium potency topical corticosteroid. It relieves inflammation and itching in corticosteroid-responsive skin conditions, and can be used in children from 1 year of age. Pharmaceutical companies can source alclometasone 0.05% cream and ointment through out-licensing, supply or technology transfer. Dossiers are available in US ANDA and EU CTD formats.

Alclometasone key facts

Alclometasone manufacturers and licensing history

The FDA approved alclometasone dipropionate cream and ointment as Aclovate on 14 December 1982. Aclovate was marketed for years by GlaxoSmithKline and is now under Fougera. The original NDAs are listed as discontinued, but the FDA has determined this was not for safety or effectiveness reasons, so generics can still reference them.

Taro received the first US generic approval, for alclometasone ointment 0.05%, in July 2004. At that time, US sales of Aclovate ointment were about USD 2.5 million a year. Several other AB-rated generic creams and ointments followed in 2004–2009.

Alclometasone dipropionate API is a steroid, so buyers should confirm GMP status, a US DMF and containment capability for corticosteroid production before choosing a dossier partner.

Alclometasone dosage forms and dossier types

Alclometasone dipropionate is approved as 0.05% cream and 0.05% ointment. Generic alclometasone manufacturers develop both forms, referencing Aclovate.

Alclometasone regulatory and patent status

The FDA approved Aclovate cream and ointment on 14 December 1982. The original NDAs are now discontinued, but not for safety or effectiveness reasons, so they remain valid references. The first US generic, Taro's ointment, was approved in July 2004, and several AB-rated generics are on the market. Alclometasone is long off-patent.

Alclometasone mechanism of action and therapeutic use

Alclometasone dipropionate is a synthetic corticosteroid. It reduces inflammation by suppressing the release of inflammatory mediators and reducing blood vessel dilation in the skin. It is used for the inflammatory and itchy symptoms of corticosteroid-responsive dermatoses, such as eczema and dermatitis, in adults and children from 1 year of age. It should not be used under nappies or occlusive dressings in children.

Alclometasone licensing and sourcing

Alclometasone 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 alclometasone manufacturers on Pipelinepharma.

Frequently asked questions about alclometasone

Who are the main alclometasone manufacturers? Fougera holds the original Aclovate applications. US generic alclometasone cream and ointment are made by Taro and several other companies.

Is there a generic version of alclometasone? Yes. Taro received the first US generic approval, for alclometasone ointment 0.05%, in July 2004. Several AB-rated generic creams and ointments are now available.

Is an alclometasone EU CTD dossier available for licensing? Yes. Alclometasone 0.05% cream and ointment dossiers in EU CTD format can be licensed. Buyers should check which reference product is authorised in each target country.

What forms and strengths of alclometasone are available? Alclometasone dipropionate is available as 0.05% cream and 0.05% ointment, in 15 g, 45 g and 60 g tubes.

Can alclometasone be used in children? Yes, from 1 year of age. Use for longer than 3 weeks in children has not been studied, and it should not be used under nappies.