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Norpramin (DESIPRAMINE)
Norpramin (Desipramine) is a tricyclic antidepressant developed by Sanofi Aventis US and currently owned by Validus Pharms. It targets the sodium-dependent dopamine transporter to exert its therapeutic effects. Originally approved by the FDA in 1964 for the treatment of depressive disorder, Norpramin is now available as a generic medication with no active Orange Book patents. The drug has a half-life of 22.0 hours and bioavailability of 82%. It is one of the many generic options available for depressive disorder treatment.
At a glance
| Generic name | DESIPRAMINE |
|---|---|
| Sponsor | Validus Pharms |
| Drug class | Tricyclic Antidepressant |
| Target | Sodium-dependent dopamine transporter |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
- Depressive disorder
Boxed warnings
- Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of desipramine hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Desipramine hydrochloride is not approved for use in pediatric patients ( See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use .)
Common side effects
- Sudden death
- Myocardial infarction
- Stroke
- Hypertension
- Hypotension
- Arrhythmias
- Ventricular fibrillation
- Ventricular tachycardia
- Premature ventricular contractions
- Seizures
- Neuroleptic Malignant Syndrome
- Gynecomastia
Drug interactions
- cimetidine
- duloxetine
- fluconazole
- fluoxetine
- fluvoxamine
- isocarboxazid
- itraconazole
- ketoconazole
- linezolid
- methadone
- pargyline
- paroxetine
Key clinical trials
- Irritable Bowel Syndrome (IBS) Functional Magnetic Resonance Imaging (fMRI) With Desipramine (NA)
- Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization (PHASE4)
- Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant (NA)
- Tricyclic Antidepressants (TCAs) on Gastric Emptying (NA)
- Desipramine in Infantile Neuroaxonal Dystrophy (INAD). (PHASE4)
- A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors (PHASE3)
- Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment (NA)
- A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Norpramin CI brief — competitive landscape report
- Norpramin updates RSS · CI watch RSS
- Validus Pharms portfolio CI