Prescription medicine

Icotrokinra Brand names: Icotyde

Icotrokinra (Icotyde) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the icotrokinra FDA label on DailyMed (effective March 17, 2026, Janssen Biotech, Inc.); the NDA 220149 record on Drugs@FDA; every icotrokinra label on DailyMed.

Highlights of the record

FDA label of March 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

Forms and strengths

200 mg

Film-coated tablet.

On the market

Earliest approval on file: March 17, 2026 Icotyde, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: November 19, 2041 Icotyde 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: 121 through July 30, 2026

What is icotrokinra used for?

From the label: indications and usage
ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

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

Psoriasis

Source: FDA drug label (ICOTYDE), Janssen Biotech, Inc., effective March 17, 2026 (SPL set aee3c963-edc0-4252-8769-cdf6c7cdc21a), via openFDA; the full label on DailyMed

What does the patient leaflet for icotrokinra 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 ICOTYDE?
Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE. Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including: fever, sweat, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal See "What are the possible side effects of ICOTYDE?" for more information about side effects.

From the patient leaflet: How should I store ICOTYDE?
Store ICOTYDE at room temperature between 68°F to 77°F (20°C to 25°C). Store ICOTYDE in the original bottle to protect from moisture. The ICOTYDE bottle comes with a child-resistant cap and contains a desiccant packet to keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant packet. Keep ICOTYDE and all medicines out of the reach of children.

Source: FDA drug label (ICOTYDE), Janssen Biotech, Inc., effective March 17, 2026 (SPL set aee3c963-edc0-4252-8769-cdf6c7cdc21a), via openFDA; the full label on DailyMed

Is there a generic for icotrokinra (Icotyde)?

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

The Orange Book lists 3 patents for Icotyde tablets: the compound patent runs to January 14, 2041, and the last listed entry to November 19, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2026 earliest approval on file
2041 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 icotrokinra?

The FDA Adverse Event Reporting System holds 121 reports that list icotrokinra among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 6 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.

The most reported reactions

Headache (named in the label)18
Nausea (named in the label)16
Fatigue (named in the label)11
Product Dose Omission Issue (a use or a product term, not a reaction)9
Psoriasis (a use or a product term, not a reaction)6
Rash6
Diarrhoea (named in the label)5
Abdominal Discomfort (named in the label)4

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 icotrokinra?

4 other medicines are given the same way (oral) and in the same FDA class as icotrokinra 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
Deucravacitinib	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 icotrokinra

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

What next?

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