NDAINJECTIONINJECTABLE
Approved
Apr 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
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 tricyclic antidepressant approved since 1961 that inhibits reuptake of norepinephrine and serotonin in the central nervous system. It is indicated for peripheral neuropathy and HIV infection management. The drug works by potentiating neuronal activity through blockade of biogenic amine reuptake rather than direct CNS stimulation.
LOE Approaching
Product approaching loss of exclusivity with minimal commercial momentum; small team focus on managed decline and generic transition planning.
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.