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Amphetamine Sulfate (AMPHETAMINE SULFATE)
Amphetamine Sulfate is a central nervous system stimulant originally developed by UCB INC and currently owned by Azurity. It targets the sodium-dependent dopamine transporter to increase dopamine levels in the brain, treating conditions such as attention deficit hyperactivity disorder, narcolepsy, and obesity. Amphetamine Sulfate has been FDA-approved since 1955 and is available as a generic medication from multiple manufacturers. Its half-life is approximately 7.3 hours, and it is a small molecule modality. Key safety considerations include potential for abuse and dependence.
At a glance
| Generic name | AMPHETAMINE SULFATE |
|---|---|
| Sponsor | Azurity |
| Drug class | Central Nervous System Stimulant |
| Target | Sodium-dependent dopamine transporter |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1955 |
| Annual revenue | 172 |
Approved indications
- Attention deficit hyperactivity disorder
- Narcolepsy
- Obesity
Boxed warnings
- 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 ).
Common side effects
- Psychotic episodes
- Rhabdomyolysis
- Cardiomyopathy
- Impotence
- Changes in libido
- Frequent or prolonged erections
- Exacerbation of motor and phonic tics and Tourettes syndrome
- Tachycardia
- Elevation of blood pressure
- Palpitations
- Overstimulation
- Restlessness
Drug interactions
- Ioflupane I-123
- isocarboxazid
- pargyline
- phenelzine
- tranylcypromine
Key clinical trials
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- tTIS Targeted of the Striatum as an Intervention for MUD Patients (NA)
- The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine (PHASE4)
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (PHASE2)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (PHASE2,PHASE3)
- Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR (NA)
- Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amphetamine Sulfate CI brief — competitive landscape report
- Amphetamine Sulfate updates RSS · CI watch RSS
- Azurity portfolio CI