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Sold as Yesintek. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ustekinumab-Kfce (sold as Yesintek), first approved Apr 30, 2025, with 1 new use approved and 0 published complete response letters.
First approved: Apr 30, 2025
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $28.0M
Orphan exclusivity until: Aug 28, 2033
First approved in the EU: Jan 16, 2009
First approved in Japan: Jan 21, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Yesintek
Part D
$27.9M
New
4,262
YESINTEK
Part B
$143K
New
27
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
YESINTEK 45 MG/0.5 ML SYRINGE: $2855.60 per MLBrand · new this year
YESINTEK 90 MG/ML SYRINGE: $2903.40 per MLBrand · new this year
First approved in Japan 171 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
1) Stelara1) A drug with a new indication for the remission induction therapy of moderate to severe ulcerative colitis (for use only in patients who have not… · Janssen Pharmaceutical K.K. · Mar 25, 2020
Stelara, new approval(1) A drug with a new route of administration indicated for the induction therapy for moderate to severe active Crohn's disease (for use only in patients… · Janssen Pharmaceutical K.K. · Mar 30, 2017 · Review report
Stelara, new ingredientA drug with a new active ingredient indicated for the treatment of plaque psoriasis and psoriatic arthritis in patients who have not responded sufficiently… · Janssen Pharmaceutical K.K. · Jan 21, 2011 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
