ADDERALL 12.5
LOE Approachingamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
NDAORALTABLET
Approved
Jan 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ADDERALL 12.5 (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate) by Teva is non-catecholamine sympathomimetic amines with cns stimulant activity. Approved for attention deficit hyperactivity disorder (adhd) in patients 13 years, older [see clinical studies ()], older and 1 more indications. First approved in 1960.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Adderall 12.5 is an oral tablet combining four amphetamine salts (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate) indicated for ADHD in patients 13 years and older. It is a CNS stimulant with sympathomimetic activity, though its exact mechanism of therapeutic action in ADHD remains unknown.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity, signaling potential downsizing or transition of core brand team to next-generation formulations or line extensions.
Mechanism of Action
non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.