Deucravacitinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Sotyktu

Category: Active Pharmaceutical Ingredient

Deucravacitinib is an oral, allosteric TYK2 inhibitor for plaque psoriasis and psoriatic arthritis. It is sourced by generic formulators, CDMOs and R&D teams.

Product Description:

Deucravacitinib is an oral TYK2 inhibitor that binds the enzyme's regulatory (pseudokinase) domain rather than its active site, which makes it selective over the related JAK1, JAK2 and JAK3 enzymes and dampens IL-23, IL-12 and type I interferon signalling. It is approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and in the US also for active psoriatic arthritis in adults (reference brand: Sotyktu).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 14 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2033). European Union: Patent expiry; entry not confirmed (2033).

Handling and quality points

The deuterated N-methyl amide means isotopic purity is part of the specification: ask how the supplier limits the d0 to d2 species and how it is measured. Solubility depends strongly on pH, and the reference tablet contains hypromellose acetate succinate, so confirm the solid form and particle properties your formulation needs. Standard checks also apply: residual solvents, mutagenic impurity control and a nitrosamine risk assessment.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.