Tetrabenazine

Treats chorea associated with Huntington's disease. Sold as Xenazine. Every FDA application for this active ingredient: 1 branded and 11 generic.

As of Nov 15, 2026, FDA lists 12 applications for Tetrabenazine (sold as Xenazine), first approved Aug 15, 2008, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 15, 2008
Applications: 12
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $41.0M
First approved in Japan: Dec 25, 2012

Medicare Spending

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


Tetrabenazine	Part D	$34.7M	-15%	4,687
Xenazine	Part D	$6.2M	+11%	23

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

TETRABENAZINE 12.5 MG TABLET: $0.674 per unitGeneric · -13% in a year
TETRABENAZINE 25 MG TABLET: $1.30 per unitGeneric · -2% in a year

Orphan Designations (FDA)

3 designations, 1 approved for the designated use; see all orphan designations

Treatment of Tourette's Syndrome in school-age children, ages 5-16Valeant International (Barbados) SRL · designated Jul 1, 2009
Treatment of moderate/severe tardive dyskinesia.Prestwick Pharmaceuticals, Inc. · designated May 12, 1998
Treatment of Huntington's diseasePrestwick Pharmaceuticals, Inc · designated Dec 11, 1997 · approved Aug 15, 2008

Approvals in Japan (PMDA)

First approved in Japan 52 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Choreazine, new ingredientA drug with a new active ingredient indicated for the treatment of chorea associated with Huntington's disease. · Alfresa Pharma Corporation · Dec 25, 2012

Applications

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


Aug 15, 2008	XenazineNDA 21894 · New molecular entity	Bausch	9	Marketed
Aug 17, 2015	TetrabenazineANDA 206129	Sun Pharm	2	Discontinued
Feb 3, 2016	TetrabenazineANDA 204574	Hetero Labs Ltd V	1	Marketed
Jan 31, 2017	TetrabenazineANDA 207682	Mylan	1	Marketed
Jul 7, 2017	TetrabenazineANDA 206686	Actavis Labs Fl Inc	1	Marketed
Dec 18, 2017	TetrabenazineANDA 208826	Bionpharma	0	Marketed
Jan 8, 2018	TetrabenazineANDA 209284	Dr Reddys	0	Marketed
Apr 20, 2018	TetrabenazineANDA 210544	Chartwell Rx	0	Marketed
Apr 8, 2019	TetrabenazineANDA 209739	Hikma	0	Discontinued
Jan 22, 2020	TetrabenazineANDA 213316	Piramal	0	Marketed
Mar 17, 2020	TetrabenazineANDA 206093	Apotex	1	Marketed
Dec 4, 2020	TetrabenazineANDA 213621	Ajanta Pharma 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