NDAORALTABLET
Approved
Jul 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
LITHANE (lithium carbonate) by R-Pharm US is 12. First approved in 1985.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LITHANE (lithium carbonate) is an oral tablet approved for bipolar I disorder and acute bipolar depression, representing one of the oldest mood-stabilizing agents in psychiatry. The mechanism of action remains unknown despite decades of clinical use. It is completely absorbed in the upper GI tract with peak concentrations occurring 15 minutes to 3 hours post-dose and is primarily eliminated renally without hepatic metabolism.
LOE Approaching
LOE approaching status indicates declining market exclusivity and shrinking commercial teams; positions roles in lifecycle management and generic transition planning.
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.