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 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lithium carbonate is an oral small-molecule salt used primarily in the treatment of bipolar disorder, particularly for acute mania and maintenance therapy. It is one of the oldest psychiatric medications, with a narrow therapeutic window requiring careful monitoring of serum levels and renal/thyroid function. The mechanism involves modulation of neurotransmitter activity and intracellular signaling pathways, though the exact neurobiological basis remains incompletely understood.
LOE Approaching
With LOE approaching and intense generic competition (60/100 competitive pressure), the brand team is likely consolidating and focused on managed care contracting 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 May 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
15 enrolled
PharmacokineticsNeurology
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
Started Jun 2024
24 enrolled
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Career Relevance
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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.