NDAORALTABLET
Approved
Dec 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
LIMBITROL (amitriptyline hydrochloride; chlordiazepoxide) by Molecular Devices is clinical pharmacology amitriptyline hydrochloride is an antidepressant with sedative effects. Approved for depression, anxiety, insomnia. First approved in 1977.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Limbitrol is a fixed-dose combination oral tablet containing amitriptyline hydrochloride (a tricyclic antidepressant) and chlordiazepoxide (a benzodiazepine anxiolytic). It treats depression, anxiety, and insomnia by inhibiting reuptake of norepinephrine and serotonin while providing anxiolytic and sedative effects. The combination targets patients with concurrent depressive and anxiety symptoms.
LOE Approaching
Limbitrol is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a declining brand lifecycle that will require defensive strategy or lifecycle extension efforts from the brand team.
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 (3)
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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.