Viewing data from:

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

6 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Fresenius Kabi USA, LLC FDA-2025-P-1097 · 7 docket documents 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	Granted	Fresenius Kabi USA, LLC
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2012-P-0992 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Potassium Acetate Injection, USP 4 mEq/mL in a 50 ml glass vial suitable for submission in an ABBREVIATED New Drug Applica	Other	2012-09-25	Withdrawn	—
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2012-P-0983 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Potassium Acetate Injection, USP 2 mEq/mL in a 100 ml glass vial suitable for submission of an ANDA, using Hospira's Potas	Other	2012-09-17	Withdrawn	—
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2012-P-0984 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA find Potassium Acetate Injection, USP 2 mEq/mL in a 20 mL glass vial suitable for submission as an ANDA, with the only difference	Other	2012-09-17	Withdrawn	—
Citizen Petition from APP Pharmaceuticals LLC FDA-2009-P-0102 · 5 docket documents 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
APP Pharmaceuticals, LLC - Citizen Petition FDA-2009-P-0108 · 3 docket documents APP Pharmaceuticals LLC filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Potassium Acetate Injection USP, asking permission to increase the total drug content from 40 m	Other	2009-02-26	Granted	—

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

Clinical Trials

283 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 196 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Targeted Potassium Levels for Prevention of ICD Therapy NCT03833089	Phase 4	Active	Rigshospitalet, Denmark	1,200	2019-03-01 → 2035-04-01
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.NCT03252808	Phase 1	Active	Takara Bio Inc.	36	2017-09-25 → 2035-03-31
Potassium Supplementation in CKD NCT03253172	N/A	Active	Erasmus Medical Center	532	2017-07-01 → 2026-10-01
Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans NCT04101188	N/A	Recruiting	University of Delaware	90	2020-01-16 → 2026-07-31
A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures NCT02115776	N/A	Completed	University of Santiago de Compostela	266	2014-01 → 2015-05
Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia NCT02258763	Phase 4	Completed	University of Malaya	19	2014-11 → 2018-10
Vascular Effects of Dietary Potassium NCT03265353	N/A	Completed	University of Delaware	47	2013-07-25 → 2019-09-22
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)NCT00739674	Phase 3	Completed	Organon and Co	992	2008-02-01 → 2010-01-01
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)NCT00756938	Phase 3	Completed	Organon and Co	101	2009-03-01 → 2012-08-14
AUGMENTIN 1gm In Skin And Soft Tissue Infection NCT00343135	Phase 4	Completed	GlaxoSmithKline	195	2004-12 → 2005-03

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

Medicare Part D Spending

CMS annual spending data for Potassium Acetate (2024)

Total Spending

$2K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$0.29

Spending Trend

$3K(2019)→$12K(2020)→$9K(2021)→$733.81(2022)→$3K(2023)→$2K(2024)

YoY Change:+64.6%

5yr CAGR:+38.9%

Source: CMS Medicare Part D Spending by Drug (2024). 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.