NDAORALTABLETPriority Review
Approved
Apr 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
ELAVIL (amitriptyline hydrochloride) by AstraZeneca is clinical pharmacology amitriptyline hydrochloride is an antidepressant with sedative effects. Approved for peripheral neuropathy, hiv infection. First approved in 1961.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELAVIL (amitriptyline hydrochloride) is a first-generation tricyclic antidepressant approved in 1961 that inhibits the reuptake of norepinephrine and serotonin in the central nervous system. It is indicated for peripheral neuropathy and HIV infection-related conditions, with mechanism of action centered on potentiating neuronal biogenic amine activity. The oral tablet formulation remains a legacy product with established clinical utility in neuropathic pain management.
LOE Approaching
As a legacy product approaching LOE with minimal commercial investment, the brand team is likely small and focused on defending market share against generic erosion rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor, and it does not act primarily by stimulation of the central nervous system. Amitriptyline inhibits the membrane pump…
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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.