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POTASSIUM CHLORIDE

NDA

POTASSIUM CHLORIDE | N007865 | ELI LILLY AND CO

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

9 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - Micro-K LS -Orange Book: Approved Drug Products with Therapeut... FDA-2020-P-2181 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Micro-K LS seeking to address its listing in the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), which classifies approved drugs and their therapeutic equivalence ratings for generic drug approval pu	Suitability	2020-11-12	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 2 - Micro-K Labeling RE Suitability Petition from Hyman, Phelps & ... FDA-2020-P-2181 Hyman, Phelps & McNamara, P.C. filed a petition regarding labeling suitability for Micro-K, a potassium chloride product. The petition requests that the FDA take action concerning the product's labeling to address suitability-related issues, though specific regulatory mechanisms and detailed request	Suitability	2020-11-12	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 3 - Proposed Micro-K LS Labeling RE Suitability Petition from Hyma... FDA-2020-P-2181	Suitability	2020-11-12	Granted	Hyman, Phelps & McNamara, P.C.
ATTACHMENT 3 HIGHLIGHTS OF PRESCRIBING INFORMATION POTASSIUM CHLORIDE extende... FDA-2020-P-2005 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding potassium chloride extended-release tablets, requesting FDA evaluation of the appropriateness of the product formulation and regulatory pathway for approval or continued marketing of this potassium supplementation medication.	Suitability	2020-09-23	Granted	HYMAN, PHELPS & MCNAMARA, P.C.
ATTACHMENT 2 HIGHLIGHTS OF PRESCRIBING INFORMATION K-TAB (potassium chloride)... FDA-2020-P-2005 The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding K-TAB (potassium chloride) extended-release tablets. The petition requested FDA evaluation of the suitability of this product, though the specific regulatory action sought is not detailed in the provided text excerpt.	Suitability	2020-09-23	Granted	HYMAN, PHELPS & MCNAMARA, P.C.
Citizen Petition from Lachman Consultant Services, Inc. FDA-2001-P-0412 Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Potassium Chloride Extended Release Tablets, 15 mEq suitable for submission as an abbreviated new drug application b	Other	2019-09-04	Granted	Lachman Consultant Services, Inc.
Citizen Petition from KV Pharmaceutical Company FDA-1996-P-0022 KV Pharmaceutical Company filed this citizen petition under Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for Potassium Chloride Extended-release Microparticle Packets in 10 mEq and 20 mEq strengths, which would have	Other	2016-09-21	Granted	KV Pharmaceutical Company
Citizen Petition from NuTek Food Science LLC FDA-2016-P-1826 NuTek Food Science LLC filed this citizen petition under Section 401 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner issue guidance recognizing "potassium salt" as an additional common or usual name for potassium chloride as defined in 21 C.F.R. § 184.1622, to allow	Other	2016-06-28	Withdrawn	NuTek Food Science LLC
Foley & Lardner LLP - Citizen Petition FDA-2008-P-0412 Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and	505(q)	2008-07-18	Denied	—

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

Clinical Trials

23 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Potassium Supplementation in CKD NCT03253172	N/A	Active	Erasmus Medical Center	532	2017-07-01 → 2026-10-01
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy NCT07238400	Phase 2	Recruiting	Massachusetts General Hospital	90	2026-03-20 → 2029-03-30
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults NCT00357214	N/A	Completed	Tufts University	171	2006-09 → 2008-04
Constipation Associated With Irritable Bowel Syndrome (IBS-C)NCT00796354	Phase 3	Completed	Norgine	210	2008-11 → 2010-02
Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity NCT04519164	Phase 4	Completed	Brigham and Women's Hospital	79	2020-12-01 → 2025-09-17
Uric Acid and Hypertension in African Americans NCT00241839	Phase 3	Completed	University of Florida	150	2005-08 → 2011-05
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension NCT02653560	Phase 4	Completed	University of Texas Southwestern Medical Center	30	2012-09 → 2015-01
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter NCT01818583	Phase 4	Completed	Diakonhjemmet Hospital	143	2013-03 → 2017-11
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension NCT01682837	Phase 2	Completed	University of Texas Southwestern Medical Center	35	2012-10 → 2015-03
Effectiveness of a Homecare Dentin Hypersensitivity Gel NCT02128633	Phase 2/3	Completed	Universidade Federal de Santa Maria	126	2009-11 → 2014-03

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

Medicare Part D Spending

CMS annual spending data for Potassium Chloride (2024)

Total Spending

$2K

Total Claims

103

Beneficiaries

Avg Cost/Unit

$0.04

Spending Trend

$1K(2019)→$6K(2020)→$5K(2021)→$2K(2022)→$2K(2023)→$2K(2024)

YoY Change:-22.7%

5yr CAGR:-1.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs6 inactive

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

KLINGE CHEMICALS LTDPOTASSIUM CHLORIDE USP

DMF 39531980

AURORIUM LLCPOTASSIUM CHLORIDE

DMF 54401984

DEAD SEA WORKS LTDPOTASSIUM CHLORIDE

DMF 165352003

K+S MINERALS AND AGRICULTURE GMBHPOTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP

DMF 255952012

NANDU CHEMICAL INDUSTRIESPOTASSIUM CHLORIDE BP

DMF 258402011

ALIVUS LIFE SCIENCES LTDPOTASSIUM CHLORIDE USP

DMF 286512014

VM CHEMICALSPOTASSIUM CHLORIDE BP

DMF 290402015

MACCO ORGANIQUES SROPOTASSIUM CHLORIDE

DMF 318512017

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 368742023

THINQ PHARMA-CRO LTDPOTASSIUM CHLORIDE USP

DMF 385732023

MAITHRI DRUGS PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 401392024

EMNAR PHARMA PRIVATE LTDPOTASSIUM CHLORIDE

DMF 409112024

MUBY CHEM PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 411312025

KV PHARMACEUTICAL COInactivePOTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG

DMF 28181977

HEICO CHEMICALS DIV WHITTAKER CORPInactivePOTASSIUM CHLORIDE

DMF 52211983

KALI UND SALZ AGInactivePOTASSIUM CHLORIDE USP PRODUCED IN THE HERINGEN (GERMANY) PLANT.

DMF 55481984

MALLINCKRODT CHEMICAL INCInactivePOTASSIUM CHLORIDE

DMF 80191989

EURAND AMERICA INCInactivePOTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE

DMF 89961991

WUHAN SHIJI PHARMACEUTICAL CO LTDInactivePOTASSIUM CHLORIDE

DMF 206162007

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

Products (1)

#002 — 2MEQ/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.