DYANAVEL XR 15 (amphetamine)
DYANAVEL XR 15 is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder; Obesity.
Details
- Status
- Prescription
- First Approved
- 2021-11-04
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
DYANAVEL XR 15 Approval History
What DYANAVEL XR 15 Treats
3 indicationsDYANAVEL XR 15 is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Narcolepsy
- Attention Deficit Hyperactivity Disorder
- Obesity
DYANAVEL XR 15 Boxed Warning
ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate tablets have 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 amphetamine sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for...
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate tablets have 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 amphetamine sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, 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 amphetamine sulfate tablets 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 DRUG ABUSE AND DEPENDENCE ).
DYANAVEL XR 15 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 DYANAVEL XR 15
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03242772 results posted | Pro00085179 1P50HD093074-01 | Ph 2 | terminated | Impact of Combined Medication and Behavioral Treatment for ASD & ADHD |
| NCT02959892 results posted | TAK-041-1002 U1111-1184-1947, 2016-002346-23 | Ph 1 | completed | A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS) |
| NCT02020408 results posted | 090661 R01MH092793 | Ph 4 | completed | Monoamine Contributions to Neurocircuitry in Eating Disorders |
| NCT00733993 results posted | DA09262 P50DA009262, DPMCDA | Ph 1, Ph 2 | completed | Caffeine and Cocaine |
Active Pipeline
Ongoing clinical trials by development phase
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.
DYANAVEL XR 15 FDA Label Details
Indications & Usage
FDA Label (PDF)DYANAVEL XR 15 is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder; Obesity.
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate tablets have 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 amphetamine sulfate, can result in overdose and death ( see ...
DYANAVEL XR 15 Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for DYANAVEL XR 15
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 20 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.