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POTASSIUM ACETATE

NDA

POTASSIUM ACETATE | N018896 | HOSPIRA 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Fresenius Kabi USA, LLC FDA-2025-P-1097 Fresenius Kabi USA, LLC submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an ANDA for Potassium Acetate Injection, USP 400 mEq/200 mL (2 mEq/mL) Pharmacy Bulk Package vials, a new strength based on the Reference Li	Suitability	2025-04-18	Open	Fresenius Kabi USA
Citizen Petition from APP Pharmaceuticals LLC FDA-2009-P-0102 APP Pharmaceuticals LLC filed a citizen petition requesting that the FDA modify the Orange Book listing for potassium acetate in plastic container 2 mEq/mL, an injectable solution originally approved under NDA 018896 to Hospira on July 20, 1984. The specific regulatory action requested is not detail	Other	2009-02-26	Granted	APP Pharmaceuticals LLC

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 Potassium Acetate (2023)

Total Spending

$3K

Total Claims

105

Beneficiaries

Avg Cost/Unit

$0.18

Spending Trend

$3K(2019)→$12K(2020)→$9K(2021)→$733.81(2022)→$3K(2023)

YoY Change:+396.5%

5yr CAGR:+39.1%

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

API Supply Chain6 active DMFs

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

VASA PHARMACHEM PVT LTDPOTASSIUM ACETATE BP/EP/USP

DMF 360322021

HARMAN FINOCHEM LTDPOTASSIUM ACETATE USP

DMF 370192022

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM ACETATE USP

DMF 380752023

QUALITY CHEMICALS SLPOTASSIUM ACETATE

DMF 392712023

MUBY CHEM PRIVATE LTDPOTASSIUM ACETATE USP

DMF 411362025

MAITHRI DRUGS PRIVATE LTDPOTASSIUM ACETATE USP

DMF 425322025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 24, 2002	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MEQ/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 20, 1984

No patent or exclusivity listings for this strength.