Febuxostat

Manages hyperuricemia. Sold as Uloric. Every FDA application for this active ingredient: 1 branded and 16 generic.

As of Nov 14, 2026, FDA lists 17 applications for Febuxostat (sold as Uloric), first approved Feb 13, 2009, with 2 new uses approved and 0 published complete response letters.

First approved: Feb 13, 2009
Applications: 17
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $33.9M
First approved in the EU: Apr 21, 2008
First approved in Japan: Jan 21, 2011

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Febuxostat	Part D	$30.6M	-17%	84,131
Uloric	Part D	$3.3M	-20%	1,322

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

FEBUXOSTAT 40 MG TABLET: $0.188 per unitGeneric · -24% in a year
FEBUXOSTAT 80 MG TABLET: $0.250 per unitGeneric · -26% in a year
ULORIC 40 MG TABLET: $10.53 per unitBrand · 0% in a year
ULORIC 80 MG TABLET: $10.55 per unitBrand · +0% in a year

Approvals in the EU (EMA)

First approved in the EU 10 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Febuxostat Krka, genericKRKA tovarna zdravil d.d. Novo mesto · Mar 28, 2019
Febuxostat Viatris (previously Febuxostat Mylan), genericViatris Limited · Jun 15, 2017
Adenuric, new substanceMenarini International Operations Luxembourg S.A. (MIOL) · Apr 21, 2008

Approvals in Japan (PMDA)

First approved in Japan 23 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Feburic(1) A drug with a new additional pediatric dosage and other characteristics indicated for the treatment of gout and hyperuricemia. · Teijin Pharma Limited · Jun 26, 2023
FeburicDrugs with a new additional indication and a new dosage for the treatment of hyperuricemia in patients receiving cancer chemotherapy. · Teijin Pharma Limited · May 23, 2016 · Review report
Feburic, new ingredientDrugs with a new active ingredient indicated for the treatment of gout and hyperuricemia. · Teijin Pharma Limited · Jan 21, 2011 · Review report

Clinical Trials

19 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With HyperuricemiaHyperuricemia, Renal Insufficiency, Chronic · Nishtar Medical University	Not applicable	Active, not recruiting	Sep 30, 2026
Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage PatientsIntracranial Hemorrhage · Tanta University	Phase 2	Recruiting	Jul 14, 2026
Clinical Trial of BR2251 Tablets for Patients With Primary Gout and HyperuricemiaGout and Hyperuricemia · BioRay Pharmaceutical Co., Ltd.	Phase 2	Not yet recruiting	Mar 27, 2026
Boosting Osimertinib Blood Brain Barrier PenetrationNon-Small Cell Lung Cancer · Maastricht University Medical Center	Phase 2	Recruiting	Mar 20, 2026
Tigulixostat (IBI128) vs Febuxostat in GoutGout · Innovent Biologics Technology Limited (Shanghai R&D Center)	Phase 3	Active, not recruiting	Feb 17, 2026
HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-EffectivenessGout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis · Haiphong University of Medicine and Pharmacy	Phase 4	Not yet recruiting	Jan 27, 2026
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and HyperuricemiaPrimary Gout and Hyperuricemia · Jiangsu HengRui Medicine Co., Ltd.	Phase 2	Recruiting	Jan 23, 2026
Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCTGout, Obesity · XueMei Guo	Not applicable	Not yet recruiting	Jan 8, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 13, 2009	UloricNDA 21856 · New molecular entity	Takeda Pharms USA	9	Marketed
Jul 1, 2019	FebuxostatANDA 205385	Pharmobedient	1	Discontinued
Jul 1, 2019	FebuxostatANDA 205421	Alembic	1	Marketed
Jul 1, 2019	FebuxostatANDA 205467	Sun Pharm	1	Marketed
Oct 15, 2019	FebuxostatANDA 205414	Hikma	1	Marketed
Dec 30, 2019	FebuxostatANDA 210292	Regcon Holdings	1	Marketed
Dec 30, 2019	FebuxostatANDA 210461	Msn	1	Marketed
Jun 2, 2020	FebuxostatANDA 213069	Sunshine	1	Marketed
Oct 22, 2020	FebuxostatANDA 205374	Dr Reddys	1	Marketed
Dec 7, 2021	FebuxostatANDA 212924	Alkem Labs Ltd	1	Marketed
Mar 28, 2022	FebuxostatANDA 206266	Prinston	2	Marketed
Jan 9, 2023	FebuxostatANDA 205443	Zydus Lifesciences	1	Marketed
Sep 28, 2023	FebuxostatANDA 207293	Macleods Pharms	0	Marketed
Oct 25, 2023	FebuxostatANDA 210741	Aurobindo Pharma Ltd	0	Marketed
Dec 19, 2023	FebuxostatANDA 211837	Torrent	0	Discontinued
Jan 17, 2024	FebuxostatANDA 205406	Lupin	0	Discontinued
—	FebuxostatANDA 211339	Beijing Sl Pharma Co Ltd	0	Discontinued

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