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 17h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOFRANIL (imipramine) is a tricyclic antidepressant (TCA) approved in 1959 that works by blocking norepinephrine reuptake at nerve endings, potentiating adrenergic synapses. It is indicated for depression and childhood enuresis, with the enuresis mechanism thought to be independent of its antidepressant effect. The drug is administered via injection as a small-molecule therapeutic.
LOE Approaching
Product is approaching loss of exclusivity with low competitive pressure (30/100), suggesting a mature, stable franchise with limited growth opportunities and a likely small, maintenance-focused commercial team.
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 growth trajectory but stable, legacy-focused career development in a generic/specialty environment. Roles emphasize cost management, niche positioning, and operational efficiency rather than innovation or market expansion.
Brand Manager (Specialty)
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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.