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 26m ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOFRANIL-PM (imipramine pamoate) is an oral tricyclic antidepressant approved in 1973 for depression, available as a capsule formulation. It works by blocking the reuptake of norepinephrine at nerve endings, potentiating adrenergic synapses in the central nervous system. The pamoate salt formulation provides sustained-release delivery compared to standard imipramine.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting smaller team and focus on cost management and generic transition planning.
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
TOFRANIL-PM offers limited career growth or visibility; with zero linked jobs and approaching LOE, the team is small and focused on defending market share against generics. This is a maintenance-mode product suited to early-career professionals seeking stable roles in a low-visibility, mature portfolio.
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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.