NDAORALCAPSULE
Approved
Mar 1973
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
TOFRANIL-PM (imipramine pamoate) by Hikma is clinical pharmacology the mechanism of action of imipramine is not definitely known. Approved for depression. First approved in 1973.
Drug data last refreshed 37m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOFRANIL-PM (imipramine pamoate) is a tricyclic antidepressant indicated for depression, approved in 1973 as an oral capsule. It works by blocking the reuptake of norepinephrine at nerve endings, potentiating adrenergic synapses and elevating mood. The pamoate salt formulation provides sustained release for once-daily dosing.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and shift toward lifecycle extension or managed decline strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of action of imipramine is not definitely known. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve…
Indications (1)
Career Relevance
Working on TOFRANIL-PM offers limited career growth potential given its LOE-approaching status and zero linked job openings; roles are primarily defensive and focused on market maintenance rather than expansion. This position is best suited for professionals seeking portfolio stabilization work or niche therapy expertise rather than high-visibility innovation.
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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.