NDAORALTABLET
Approved
Nov 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
NORPRAMIN (desipramine hydrochloride) by Bausch Health is mechanism of action available evidence suggests that many depressions have a biochemical basis in the form of a relative deficiency of neurotransmitters such as norepinephrine and serotonin. First approved in 1964.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORPRAMIN (desipramine hydrochloride) is a secondary amine tricyclic antidepressant approved in 1964 that treats depression by blocking norepinephrine reuptake in the central nervous system. It restores normal neurotransmitter levels to address biochemical deficiencies associated with depression. The drug may show earliest therapeutic effects in 2–5 days, with full benefit typically within 2–3 weeks.
LOE Approaching
As loss of exclusivity approaches, the brand team is likely focused on niche positioning and managed care retention rather than growth expansion.
Mechanism of Action
Mechanism of Action Available evidence suggests that many depressions have a biochemical basis in the form of a relative deficiency of neurotransmitters such as norepinephrine and serotonin. Norepinephrine deficiency may be associated with relatively low urinary 3-methoxy-4-hydroxyphenyl glycol…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
Started Dec 1987
36 enrolled
Depression
To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Started Dec 1987
36 enrolled
Depression
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
Started Jul 1987
36 enrolled
Depression
To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
36 enrolled
Depression
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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.