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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Saptalis Pharmaceuticals, LLC FDA-2022-P-2752 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Lithium Citrate Syrup EQ 300 mg Carbonate/5 mL (NDA N018421), held by Hikma Pharmaceuticals USA Inc., was voluntarily withdrawn from the market for safety or effectiveness reasons.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	Denied	Saptalis Pharmaceuticals

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 Citrate (2023)

Total Spending

$4K

Total Claims

Beneficiaries

Avg Cost/Unit

$0.55

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

API Supply Chain0 active DMFs1 inactive

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

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

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#001 — EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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