ADDERALL XR 15 (amphetamine aspartate) · Takeda
ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. Disorder (ADHD) in adults and pediatric patients 6 years and older.
Details
- Status
- Prescription
- First Approved
- 2001-10-11
- Revenue
- $33M (Q2-FY2026)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
Companies
ADDERALL XR 15 Approval History
What ADDERALL XR 15 Treats
2 indicationsADDERALL XR 15 is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
ADDERALL XR 15 Boxed Warning
ABUSE, MISUSE, and ADDICTION ADDERALL XR ® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ADDERALL XR, assess each patient’s risk for abuse, misuse, and addiction. Ed...
WARNING: ABUSE, MISUSE, and ADDICTION ADDERALL XR ® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ADDERALL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout ADDERALL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )] . WARNING: ABUSE, MISUSE, and ADDICTION See full prescribing information for complete boxed warning. ADDERALL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing ADDERALL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
ADDERALL XR 15 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ADDERALL XR 15
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Takeda's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADDERALL XR 15 FDA Label Details
Indications & Usage
FDA Label (PDF)ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. 1.1 Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patien...
WARNING: ABUSE, MISUSE, and ADDICTION ADDERALL XR ® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death [see Overdosage ( 10 )] , and...
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Revenue Insights
- • Q2-FY2026: $33M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.