NDAORALTABLET
Approved
Sep 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ETRAFON 2-25 (amitriptyline hydrochloride; perphenazine) by Merck & Co. is clinical pharmacology amitriptyline hydrochloride is an antidepressant with sedative effects. Approved for depression. First approved in 1969.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ETRAFON 2-25 is a fixed-dose oral combination tablet containing amitriptyline hydrochloride (a tricyclic antidepressant) and perphenazine (an antipsychotic), approved for depression. Amitriptyline works by inhibiting reuptake of norepinephrine and serotonin in the central nervous system, potentiating neurotransmitter activity. This combination formulation addresses depression with concurrent anxiety or agitation.
LOE Approaching
Product approaching loss of exclusivity with minimal current commercial investment; limited team expansion expected.
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…
Indications (1)
Career Relevance
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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.