NDAORALTABLET2 Generics Approved
Approved
Jan 1982
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
3
Data completeness
3/8 — Basic
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lithium carbonate is a small-molecule mood stabilizer indicated for bipolar disorder and major depressive disorder. Its precise mechanism of action remains unknown, though it demonstrates efficacy in stabilizing mood fluctuations. The drug is completely absorbed in the upper GI tract, undergoes no metabolism, and is primarily eliminated unchanged via renal excretion with an 18–36 hour half-life.
LOE Approaching
As a decades-old product approaching loss of exclusivity with 60% competitive pressure, the brand team is likely focused on retention strategies and managed generics rather than expansion.
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
HealthyHealthy Donors
Career Relevance
Worked on LITHIUM CARBONATE at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.