NDAORALSOLUTION
Approved
Nov 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AVENTYL (nortriptyline hydrochloride) by Signatur Biosciences is clinical pharmacology the mechanism of mood elevation by tricyclic antidepressants is at present unknown. Approved for depression. First approved in 1964.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVENTYL (nortriptyline hydrochloride) is an oral tricyclic antidepressant approved in 1964 for the treatment of depression. The mechanism of mood elevation remains incompletely understood, but the drug inhibits catecholamine transport, release, and storage while modulating histamine and serotonin activity. It is formulated as an oral solution and possesses a combination of stimulant and depressant properties in animal models.
LOE Approaching
As a legacy tricyclic antidepressant approaching loss of exclusivity with minimal documented Part D spending, AVENTYL faces significant generic erosion and likely operates with a small specialized team focused on niche market retention.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Nortriptyline hydrochloride is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor…
Indications (1)
Career Relevance
Working on AVENTYL offers limited career growth opportunities given its LOE-approaching status and zero documented linked job openings. Roles focus on defending market share and managing the transition to genericization rather than brand building or 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.