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LITHIUM CARBONATE

NDA

LITHIUM CARBONATE | N016834 | PFIZER 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from West-Ward Pharmaceutical, Corp. FDA-2006-P-0442 West-Ward Pharmaceutical Corp. filed this citizen petition requesting that the FDA determine whether Pfizer's voluntary withdrawal of Lithium Carbonate Tablets 300 mg (NDA 016834) from distribution and sale was for safety or effectiveness reasons, and if not, to permit filing of an abbreviated new d	505(q)	2008-06-24	Withdrawn	West-Ward Pharmaceutical

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lithium Carbonate (2023)

Total Spending

$7.4M

Total Claims

731,869

Beneficiaries

103,265

Avg Cost/Unit

$0.14

Spending Trend

$7.8M(2019)→$7.9M(2020)→$7.5M(2021)→$7.1M(2022)→$7.4M(2023)

YoY Change:+9.8%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs4 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

ANI PHARMACEUTICALS INCInactiveLITHIUM CARBONATE PILOT PROCESS

DMF 37781980

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveLITHIUM CARBONATE

DMF 42931981

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

Products (1)

#001 — 300MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.