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LITHIUM CITRATE

NDA

LITHIUM CITRATE | N018421 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2022-P-3125 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of an unnamed client requesting that the FDA determine whether Lithium Citrate Oral Syrup, 300 mg Carbonate/5 mL, approved under NDA 018421 and held by Hikma Pharmaceuticals USA Inc., was withdrawn for safety or effectiveness reasons pursu	505(q)	2022-12-07	Denied	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Saptalis Pharmaceuticals, LLC FDA-2022-P-2752 · 4 docket documents Saptalis Pharmaceuticals, LLC filed this petition requesting that the FDA determine whether Lithium Citrate Syrup EQ 300 mg Carbonate/5 mL (NDA N018421), held by Hikma Pharmaceuticals USA Inc., was voluntarily withdrawn from the market for safety or effectiveness reasons. Saptalis seeks this determi	505(q)	2022-11-03	Granted	Saptalis Pharmaceuticals, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

167 trials from ClinicalTrials.gov, 109 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients NCT00870311	Phase 4	Completed	Wayne State University	28	1996-03 → 2004-04
Evaluation of Lithium as a Glycogen-Synthase-Kinase-3 (GSK-3) Inhibitor in Mild Cognitive Impairment NCT02601859	N/A	Completed	University of Dundee	11	2016-08 → 2017-06
Treatment of Psychosis and Agitation in Alzheimer's Disease NCT02129348	Phase 2	Completed	New York State Psychiatric Institute	77	2014-06 → 2020-01
Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions NCT00602381	N/A	Completed	Roxane Laboratories	30	2002-11 → 2002-11
Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium NCT01919892	Phase 4	Completed	University of Sao Paulo	30	2010-09 → 2012-11
Relapse Prevention for Bipolar Type-II Disorder NCT00044616	Phase 4	Completed	University of Pennsylvania	180	2001-02 → 2007-01
Treatment and Outcome of Early Onset Bipolar Disorder NCT00048802	Phase 4	Completed	Northwell Health	40	2002-08 → 2006-08
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder NCT00107731	Phase 3	Completed	AstraZeneca	710	2004-04 → 2006-10
Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder NCT00000375	Phase 4	Completed	National Institute of Mental Health (NIMH)	—	1997-02
Effects of Lithium and Divalproex'on Brain-Derived Neurotrophic Factor in Huntington's Disease NCT00095355	Phase 2	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	35	2004-10 → 2005-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MAITHRI DRUGS PRIVATE LTDLITHIUM CITRATE USP

DMF 437392026

SOLVAY PHARMACEUTICALSInactiveLITHIUM CITRATE SYRUP

DMF 13201969

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Oct 14, 2022	SUPPL -35	View Letter (PDF)
Feb 6, 2020	SUPPL -33	View Letter (PDF)
Dec 21, 2018	SUPPL -32	View Letter (PDF)
Oct 11, 2018	SUPPL -31	View Letter (PDF)
Oct 28, 2016	SUPPL -25	View Letter (PDF)
Oct 25, 2011	SUPPL -27	View Letter (PDF)
Jan 31, 2003	SUPPL -21	View Letter (PDF)
Nov 26, 2001	SUPPL -15	View Letter (PDF)
Nov 26, 2001	SUPPL -14	View Letter (PDF)
Nov 26, 2001	SUPPL -16	View Letter (PDF)
Nov 26, 2001	SUPPL -13	View Letter (PDF)
Nov 26, 2001	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.