TOFRANIL
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
Oct 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
TOFRANIL by Novartis is clinical pharmacology the mechanism of action of tofranil is not definitely known. First approved in 1959.
Drug data last refreshed 4h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOFRANIL (imipramine) is a tricyclic antidepressant approved in 1959 for treating Major Depressive Disorder. It works by blocking the reuptake of norepinephrine at nerve endings, potentiating adrenergic synapses; it also has an established use in childhood enuresis through a mechanism distinct from its antidepressant effect. Administered via injection, it represents one of the earliest antidepressant therapies still in clinical use.
LOE Approaching
As a legacy product approaching loss of exclusivity with minimal patent protection, the brand team is likely small and focused on market defense rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of action of Tofranil 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Started Jul 2005
48 enrolled
Depression
Career Relevance
Working on TOFRANIL offers limited career growth opportunity given its approaching loss of exclusivity, minimal linked job postings, and shrinking market footprint. This role is best suited for professionals seeking stability in a legacy portfolio position rather than high-visibility growth assignments.
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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.