NDAORALTABLET
Approved
Apr 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
LITHIUM CARBONATE (lithium carbonate) by Pfizer is 12. First approved in 1970.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lithium carbonate is a small-molecule mood stabilizer indicated for bipolar disorder, acute bipolar depression, and major depressive disorder. Its exact mechanism of action remains unknown, but it is believed to modulate neurotransmitter activity in the central nervous system. It is completely absorbed from the gastrointestinal tract, not metabolized, and primarily excreted unchanged in the urine with an elimination half-life of 18–36 hours.
LOE Approaching
As a long-established generic approaching loss of exclusivity, lithium carbonate teams are likely focused on maintaining market position through cost leadership and clinical evidence rather than driving growth.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of lithium as a mood stabilizing agent is unknown. 12.3 Pharmacokinetics Absorption After oral administration, lithium is reported to be completely absorbed in the upper gastrointestinal tract. Peak serum concentrations (T max ) occur 0.25 to 3 hours…
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.