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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

70 trials from ClinicalTrials.gov, 50 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain NCT01553916	Phase 1/2	Completed	Washington University School of Medicine	19	2012-04-26 → 2017-06-05
Ketamine Plus Lithium in Treatment-Resistant Depression NCT01880593	Phase 2	Completed	Icahn School of Medicine at Mount Sinai	34	2013-07 → 2016-11
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults NCT02960763	Phase 4	Completed	Washington University School of Medicine	742	2017-02-24 → 2021-09-01
Lithium Treatment for Patients With Spinocerebellar Ataxia Type I NCT00683943	Phase 1	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	13	2008-05-18 → 2010-02-25
Prevention of Relapse & Recurrence of Bipolar Depression NCT00961961	Phase 4	Completed	University of Pennsylvania	177	2009-07-01 → 2016-09-01
Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome NCT01108068	N/A	Completed	University of Maryland, Baltimore	26	2010-07 → 2014-07
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode NCT02918097	Phase 4	Completed	Federal University of Rio Grande do Sul	78	2010-05 → 2015-09
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)NCT00790582	Phase 2	Completed	Forbes Norris MDA/ALS Research Center	109	2008-05 → 2010-03
Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode NCT01977300	Phase 3	Completed	University of British Columbia	159	2003-01 → 2011-08
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study NCT00177567	Phase 4	Completed	University of Pittsburgh	60	2001-07 → 2004-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$0.2466

per ea

Lowest NADAC/Unit

$0.0873

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054253125LITHIUM CARBONATE 600 MG CAP	$0.2466	EA	Generic	—	2026-06-17
00054852725LITHIUM CARBONATE 300 MG CAP	$0.0959	EA	Generic	—	2026-06-17
00054252725LITHIUM CARBONATE 300 MG CAP	$0.0959	EA	Generic	—	2026-06-17
00054252731LITHIUM CARBONATE 300 MG CAP	$0.0959	EA	Generic	—	2026-06-17
00054852625LITHIUM CARBONATE 150 MG CAP	$0.0873	EA	Generic	—	2026-06-17
00054252625LITHIUM CARBONATE 150 MG CAP	$0.0873	EA	Generic	—	2026-06-17

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
00054-8526-25LITHIUM CARBONATE 150MG CAP	$8.75	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00054-2526-25LITHIUM CARBONATE 150MG CAP	$5.01	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 Chain11 active DMFs7 inactive

11 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

MAITHRI DRUGS PRIVATE LTDLITHIUM CARBONATE USP

DMF 437402026

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