NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
LITHOBID (lithium carbonate) by ANI Pharmaceuticals is 12. First approved in 1979.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LITHOBID (lithium carbonate) is an oral extended-release mood stabilizer indicated for bipolar disorder, acute bipolar depression, major depressive disorder, and treatment-resistant depression. The mechanism of action remains unknown, but lithium is completely absorbed in the upper GI tract with peak serum concentrations occurring 2-6 hours post-dose. It is not metabolized and is primarily excreted unchanged in urine with an elimination half-life of 18-36 hours.
$1MPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with minimal Medicare spending and very limited claims volume, indicating a small team focused on maintenance rather than expansion.
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.