NDAORALCAPSULEPriority Review
Approved
Dec 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
6/8 — Strong
Priority Review
ANAFRANIL (clomipramine hydrochloride) by Aurobindo Pharma is clinical pharmacology pharmacodynamics clomipramine (cmi) is presumed to influence obsessive and compulsive behaviors through its effects on serotonergic neuronal transmission. Approved for depression. First approved in 1989.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANAFRANIL (clomipramine hydrochloride) is a tricyclic antidepressant that treats depression and obsessive-compulsive disorder by inhibiting serotonin reuptake in the central nervous system. The drug works through presumed effects on serotonergic neuronal transmission, with the active metabolite desmethylclomipramine contributing to clinical efficacy. It is formulated as oral capsules with nonlinear dose-dependent pharmacokinetics that require careful clinical monitoring.
$0.001BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D spending signals a small, stable team focused on managed decline and generic transition support.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Clomipramine (CMI) is presumed to influence obsessive and compulsive behaviors through its effects on serotonergic neuronal transmission. The actual neurochemical mechanism is unknown, but CMI's capacity to inhibit the reuptake of serotonin (5-HT) is thought…
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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.