Prescription medicine

Deucravacitinib Brand names: Sotyktu

Deucravacitinib (Sotyktu) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the deucravacitinib FDA label on DailyMed (effective June 30, 2026, E.R. Squibb & Sons, L.L.C.); the NDA 214958 record on Drugs@FDA; every deucravacitinib label on DailyMed.

Highlights of the record

FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for:
the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Forms and strengths

6 mg

Film-coated tablet.

On the market

Earliest approval on file: September 9, 2022 Sotyktu, Bristol; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 11, 2043 Sotyktu tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 2,800 through July 30, 2026

What is deucravacitinib used for?

From the label: indications and usage
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for:
the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use: Not recommended for use in combination with other potent immunosuppressants.
the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. […]

Conditions named in the indications of deucravacitinib's FDA labels, with every medicine labeled for each:

Psoriasis

FDA pharmacologic class: Tyrosine Kinase 2 Inhibitor.

Source: FDA drug label (SOTYKTU), NDA214958 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective June 30, 2026 (SPL set ff4d7258-5068-4cdf-9692-8cae04c3198e), via openFDA; the full label on DailyMed

What does the patient leaflet for deucravacitinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about SOTYKTU?
SOTYKTU may cause serious side effects, including: • Serious allergic reactions. Stop taking SOTYKTU and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o feel faint o swelling of your face, eyelids, lips, mouth, tongue, or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives • Infections. SOTYKTU is a medicine that affects your immune system. SOTYKTU can lower the ability of your immune system to fight infections and can increase your risk of infections. Some people have had serious infections while taking SOTYKTU, such as infections of the lungs, including pneumonia and tuberculosis (TB), and COVID-19. o Your healthcare provider should check you for infections and TB before starting treatment with SOTYKTU. o Your healthcare provider may treat you for TB before you begin treatment with SOTYKTU if you have a history of TB or have active TB. o Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with SOTYKTU. o If you get a serious infection, your healthcare provider may tell you to stop taking SOTYKTU until your infection is controlled. SOTYKTU should not be used in people with an active, serious infection, including localized infections. You should not start taking SOTYKTU if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). […]

From the patient leaflet: How should I store SOTYKTU?
Store SOTYKTU at room temperature between 68°F to 77°F (20°C to 25°C). Keep SOTYKTU and all medicines out of the reach of children.

Is there a generic for deucravacitinib (Sotyktu)?

No generic deucravacitinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 4 patents for Sotyktu tablets: the compound patent runs to November 7, 2033, and the last listed entry to February 11, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2022 earliest approval on file
2043 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for deucravacitinib?

The FDA Adverse Event Reporting System holds 2,800 reports that list deucravacitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 153 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,052, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)275
Acne (named in the label)243
Pruritus226
Rash (named in the label)195
Psoriasis (a use or a product term, not a reaction)174
Erythema153
Off Label Use (a use or a product term, not a reaction)113
Adverse Event81

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as deucravacitinib?

4 other medicines are given the same way (oral) and in the same FDA class as deucravacitinib or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Acitretin	Psoriasis	8 labelers	$2.59 per capsule 10 mg capsule	No current entry
Apremilast	Psoriasis	none listed	$90.57 per tablet 30 mg tablet	No current entry
Icotrokinra	Psoriasis	none listed	n/a	No current entry
Methoxsalen	Psoriasis	1 labeler	n/a	No current entry

Every medicine labeled for the same conditions as deucravacitinib

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to deucravacitinib: 4 medicines for the same use
Deucravacitinib side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other