Difamilast Ointment 1% (Japan also 0.3%) Suppliers & Bulk Manufacturers

Available Forms: Ointment

Available Strengths: 1% (Japan also 0.3%)

Reference Brands: Adquey (US), Moizerto (Japan) — originator Otsuka

Difamilast is a steroid-free PDE4 inhibitor ointment for mild to moderate atopic dermatitis. Otsuka launched it in Japan as Moizerto in 2021, and the US FDA approved it as Adquey in February 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.

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Product Description:

Difamilast inhibits phosphodiesterase 4 (PDE4), an enzyme inside immune and skin cells that keeps inflammatory signalling switched on. Blocking it calms the skin inflammation of eczema without a steroid. It is selective for the PDE4B subtype and is applied directly to the skin as an ointment.

Otsuka developed difamilast and launched it in Japan as Moizerto ointment in 2021, in 0.3% and 1% strengths. The US FDA approved difamilast 1% ointment as Adquey in February 2026 for mild to moderate atopic dermatitis in adults and children aged 2 and over. It is applied twice a day. Because it is not a steroid, it does not cause steroid side effects such as skin thinning.

Sourcing and licensing notes. Difamilast is patented and there is no generic. Crisaborole, another PDE4 ointment for eczema, is also listed on PharmaTradz. We handle authorised-supply enquiries and connect developers and licensees interested in the molecule ahead of patent expiry.

How Difamilast Ointment is supplied today, and licensing ahead of patent expiry

Difamilast Ointment is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Difamilast Ointment, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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