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Treats Attention Deficit Hyperactivity Disorder (ADHD). Sold as Tenex, Intuniv. Every FDA application for this active ingredient: 2 branded and 25 generic.
As of Nov 15, 2026, FDA lists 27 applications for Guanfacine Hydrochloride (sold as Tenex, Intuniv), first approved Oct 27, 1986, with 5 new uses approved and 0 published complete response letters.
First approved: Oct 27, 1986
Applications: 27
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $11.2M
First approved in the EU: Sep 17, 2015
First approved in Japan: Mar 30, 2017
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Guanfacine HCl ER
Part D
$6.5M
+41%
29,537
Guanfacine HCl
Part D
$4.5M
+4%
25,738
Intuniv
Part D
$261K
+25%
95
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
GUANFACINE 1 MG TABLET: $0.154 per unitGeneric · -2% in a year
GUANFACINE 2 MG TABLET: $0.274 per unitGeneric · -7% in a year
GUANFACINE HCL ER 1 MG TABLET: $0.132 per unitGeneric · -25% in a year
GUANFACINE HCL ER 2 MG TABLET: $0.149 per unitGeneric · -29% in a year
GUANFACINE HCL ER 3 MG TABLET: $0.176 per unitGeneric · -5% in a year
GUANFACINE HCL ER 4 MG TABLET: $0.182 per unitGeneric · -11% in a year
INTUNIV ER 1 MG TABLET: $9.35 per unitBrand · +1% in a year
INTUNIV ER 2 MG TABLET: $9.26 per unitBrand · 0% in a year
INTUNIV ER 3 MG TABLET: $9.29 per unitBrand · 0% in a year
INTUNIV ER 4 MG TABLET: $9.29 per unitBrand · 0% in a year
First approved in Japan 365 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
IntunivDrugs with a new additional indication and a new dosage for the treatment of attention- deficit/hyperactivity disorder (AD/HD) in adults. · Shionogi & Co., Ltd. · Jun 18, 2019 · Review report
Intuniv, new ingredientDrugs with a new active ingredient indicated for the treatment of pediatric attention deficit/hyperactivity disorder (AD/HD). · Shionogi & Co., Ltd. · Mar 30, 2017
Clinical Trials
10 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
Aurobindo Pharma USA
Sandoz
Impax Labs Inc
Apotex
Alembic