What development phase is LITHIUM CITRATE ANHYDROUS in?

LITHIUM CITRATE ANHYDROUS is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

LITHIUM CITRATE ANHYDROUS

FDA-approved approved Small molecule Quality 0/100

Lithium Citrate Anhydrous is a marketed drug with a key composition patent expiring in 2028. The drug's market position is bolstered by its established use, though specific revenue figures are not provided. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Generic name	LITHIUM CITRATE ANHYDROUS
Modality	Small molecule
Phase	FDA-approved
First approval	1980

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

LITHIUM CITRATE ANHYDROUS CI brief — competitive landscape report
LITHIUM CITRATE ANHYDROUS updates RSS · CI watch RSS