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Treats Attention Deficit Hyperactivity Disorder (ADHD). Sold as Focalin, Focalin Xr. Every FDA application for this active ingredient: 2 branded and 21 generic.
As of Nov 15, 2026, FDA lists 23 applications for Dexmethylphenidate Hydrochloride (sold as Focalin, Focalin Xr), first approved Nov 13, 2001, with 3 new uses approved and 0 published complete response letters.
First approved: Nov 13, 2001
Applications: 23
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $7.0M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Dexmethylphenidate HCl ER
Part D
$5.2M
+19%
8,850
Dexmethylphenidate HCl
Part D
$1.1M
+31%
6,449
Focalin XR
Part D
$519K
-51%
533
Focalin
Part D
$85K
-17%
146
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
DEXMETHYLPHENIDATE 10 MG TAB: $0.340 per unitGeneric · -8% in a year
DEXMETHYLPHENIDATE 2.5 MG TAB: $0.189 per unitGeneric · -2% in a year
DEXMETHYLPHENIDATE 5 MG TAB: $0.263 per unitGeneric · -1% in a year
DEXMETHYLPHENIDATE ER 10 MG CP: $1.39 per unitGeneric · 0% in a year
DEXMETHYLPHENIDATE ER 15 MG CP: $0.852 per unitGeneric · +7% in a year
DEXMETHYLPHENIDATE ER 20 MG CP: $1.55 per unitGeneric · -5% in a year
DEXMETHYLPHENIDATE ER 25 MG CP: $1.99 per unitGeneric · +17% in a year
DEXMETHYLPHENIDATE ER 30 MG CP: $1.44 per unitGeneric · -16% in a year
DEXMETHYLPHENIDATE ER 35 MG CP: $2.11 per unitGeneric · -11% in a year
DEXMETHYLPHENIDATE ER 40 MG CP: $1.47 per unitGeneric · +8% in a year
DEXMETHYLPHENIDATE ER 5 MG CAP: $0.985 per unitGeneric · -12% in a year
FOCALIN 10 MG TABLET: $1.33 per unitBrand · +0% in a year
Clinical Trials
2 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
Sandoz
Sun Pharm Industries
Impax Labs Inc