Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Xeljanz, Xeljanz Xr. Every FDA application for this active ingredient: 3 branded and 27 generic.
As of Nov 15, 2026, FDA lists 30 applications for Tofacitinib Citrate (sold as Xeljanz, Xeljanz Xr), first approved Nov 6, 2012, with 19 new uses approved and 0 published complete response letters.
First approved: Nov 6, 2012
Applications: 30
New uses approved: 19
Complete response letters: 0
Medicare spending, 2025: $1.05B
First approved in the EU: Mar 22, 2017
First approved in Japan: Mar 25, 2013
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 5 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
XeljanzA drug with a new additional indication and a new dosage for the remission induction and maintenance therapy of moderate to severe ulcerative colitis (for… · Pfizer Japan Inc. · May 25, 2018 · Review report
Xeljanz, new ingredientA drug with a new active ingredient for the treatment of rheumatoid arthritis in patients who have not sufficiently responded to conventional treatments. · Pfizer Japan Inc. · Mar 25, 2013 · Review report
Clinical Trials
64 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
Pfizer
Zydus Pharms
Hikma
Apotex
Sun Pharm Inds Inc