NDAORALCAPSULE2 Generics Approved
Approved
Nov 1980
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
3
Data completeness
3/8 — Basic
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lithium carbonate is a small-molecule mood stabilizer approved for bipolar disorder, acute bipolar depression, and major depressive disorder. Its mechanism of action remains incompletely understood, though it is hypothesized to work through multiple neurobiological pathways. It is completely absorbed orally with peak concentrations within 0.25–3 hours and is not metabolized, being excreted unchanged in urine with an 18–36 hour half-life.
LOE Approaching
As an approaching loss-of-exclusivity generic with high competitive pressure (60/100), lithium carbonate teams are transitioning from growth to defense and cost optimization.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
Started Apr 2026
20 enrolled
Bipolar I Disorder
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
Started May 2025
6 enrolled
PharmacokineticsNeurology
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
Started Jun 2024
24 enrolled
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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.