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LITHIUM CARBONATE

NDA

LITHIUM CARBONATE | N017812 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

73 trials from ClinicalTrials.gov — 2 recruiting, 51 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Examining Lithium's Mechanism in Bipolar Disorder NCT07750925	N/A	Not Yet Recruiting	Northumbria University	45	2026-08-01 → 2029-04-30
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 NCT07540338	Phase 1/2	Recruiting	Alzamend Neuro, Inc.	20	2026-05-11 → 2026-12
Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury NCT00431171	Phase 1	Completed	The University of Hong Kong	20	2007-09 → 2010-01
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 NCT06921590	Phase 1	Completed	Alzamend Neuro, Inc.	15	2025-05-09 → 2025-12-15
Continuation Ketamine in Major Depression NCT00548964	Phase 1	Completed	James Murrough	36	2007-10 → 2013-07
Sequential Multiple Assignment Treatment for Bipolar Disorder NCT01588457	Phase 4	Completed	The University of Texas Health Science Center at San Antonio	112	2011-06 → 2016-12
PET and MRI Brain Imaging of Bipolar Disorder NCT01880957	N/A	Completed	Stony Brook University	76	2011-11-08 → 2017-06-23
Olanzapine Versus Comparator in the Treatment of Bipolar Disorder NCT00485680	Phase 3	Completed	Eli Lilly and Company	140	2003-12 → 2005-06
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer NCT02198859	Phase 1	Completed	University of Kansas Medical Center	11	2014-04 → 2016-08
Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury NCT01354483	Phase 1/2	Completed	China Spinal Cord Injury Network	20	2011-09 → 2013-12

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs

Highest NADAC/Unit

$0.2402

per ea

Lowest NADAC/Unit

$0.0877

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054253125LITHIUM CARBONATE 600 MG CAP	$0.2402	EA	Generic	—	2026-08-19
00054852725LITHIUM CARBONATE 300 MG CAP	$0.0953	EA	Generic	—	2026-08-19
00054252725LITHIUM CARBONATE 300 MG CAP	$0.0953	EA	Generic	—	2026-08-19
00054252731LITHIUM CARBONATE 300 MG CAP	$0.0953	EA	Generic	—	2026-08-19
00054852625LITHIUM CARBONATE 150 MG CAP	$0.0877	EA	Generic	—	2026-08-19
00054252625LITHIUM CARBONATE 150 MG CAP	$0.0877	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$5.01

Highest Price

$27.86

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-2526-25LITHIUM CARBONATE 150MG CAP	$5.01	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00054-8526-25LITHIUM CARBONATE 150MG CAP	$8.75	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00054-8527-25LITHIUM CARBONATE 300MG CAP	$27.86	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs7 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

LIVENT USA CORPLITHIUM CARBONATE

DMF 12411968

ALBEMARLE CORPLITHIUM CARBONATE USP

DMF 42421981

LEK PHARMACEUTICALS DDLITHIUM CARBONATE ACTIVE SUBSTANCE

DMF 156772001

SUN PHARMACEUTICAL INDUSTRIES LTDLITHIUM CARBONATE USP

DMF 208242007

EUTICALS SPALITHIUM CARBONATE PHARMA GRADE

DMF 231752009

ALIVUS LIFE SCIENCES LTDLITHIUM CARBONATE USP

DMF 336292019

HONOUR LAB LTDLITHIUM CARBONATE

DMF 392432023

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)LITHIUM CARBONATE USP

DMF 405102025

EMNAR PHARMA PRIVATE LTDLITHIUM CARBONATE

DMF 407822024

JIANGSU NHWA PHARMACEUTICAL CO LTDLITHIUM CARBONATE USP

DMF 430932025

LYNE LABORATORIES INCInactiveLITHIUM CARBONATE TABLETS

DMF 11901968

METALLGESELLSCHAFT AGInactiveLITHIUM CARBONATE

DMF 36271979

FOOTE MINERAL COInactiveLITHIUM CARBONATE, USP

DMF 37731980

ANI PHARMACEUTICALS INCInactiveLITHIUM CARBONATE PILOT PROCESS

DMF 37781980

RUETGERS NEASE CHEMICAL CO INCInactiveLITHIUM CARBONATE, BULK

DMF 37921980

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveLITHIUM CARBONATE

DMF 42931981

LIMTECH CARBONATE INCInactiveLITHIUM CARBONATE, USP GRADE

DMF 191582006

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 14, 2022	SUPPL -36	View Letter (PDF)
Feb 6, 2020	SUPPL -34	View Letter (PDF)
Dec 21, 2018	SUPPL -33	View Letter (PDF)
Oct 11, 2018	SUPPL -31	View Letter (PDF)
Oct 28, 2016	SUPPL -27	View Letter (PDF)
Oct 25, 2011	SUPPL -28	View Letter (PDF)
Jan 31, 2003	SUPPL -23	View Letter (PDF)
Nov 26, 2001	SUPPL -16	View Letter (PDF)
Nov 26, 2001	SUPPL -11	View Letter (PDF)
Nov 26, 2001	SUPPL -13	View Letter (PDF)
Nov 26, 2001	SUPPL -14	View Letter (PDF)
Nov 26, 2001	SUPPL -17	View Letter (PDF)
Jun 14, 2001	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 300MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 150MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1987

#003 — 600MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1987