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KLOR-CON

NDA

POTASSIUM CHLORIDE | N019123 | UPSHER SMITH LABORATORIES LLC

2 strengths0 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 Lachman Consultant Services, Inc. FDA-2018-P-0870 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition 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, 8 mEq, suitable for submission as an abbreviated new drug application (ANDA), with th	Other	2018-02-26	DeniedUnverified summary	Lachman Consultant Services, Inc.

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

Clinical Trials

22 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 14 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 Preeclampsia NCT07238400	Phase 2	Recruiting	Massachusetts General Hospital	90	2026-03-20 → 2029-03-30
Constipation Associated With Irritable Bowel Syndrome (IBS-C)NCT00796354	Phase 3	Completed	Norgine	210	2008-11 → 2010-02
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity NCT01426360	N/A	Completed	Sun Yat-sen University	79	2011-09 → 2011-09
Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy NCT03992365	Phase 3	Completed	Universal Integrated Corp.	472	2019-06-10 → 2020-01-15
Fetal Reduction: Mechanical vs Chemical NCT03473158	N/A	Completed	Cairo University	50	2017-08-01 → 2019-03-31
Metabolic Acidosis in Renal Transplant Patients NCT00913796	Phase 2	Completed	University of Zurich	30	2007-12 → 2010-03
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate NCT02665117	N/A	Completed	University of Texas Southwestern Medical Center	61	2015-01 → 2022-11-04
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

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 10 NDCs (6 brand, 4 generic)

Highest NADAC/Unit

$0.1235

per ea

Lowest NADAC/Unit

$0.0838

per ea

Brand NDCs

Generic NDCs

Avg Brand: $0.1208

Avg Generic: $0.0929

23% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00245531601KLOR-CON 10 MEQ TABLET	$0.1235	EA	Brand	$0.0838	2026-08-19
00245531615KLOR-CON 10 MEQ TABLET	$0.1235	EA	Brand	$0.0838	2026-08-19
00245531611KLOR-CON 10 MEQ TABLET	$0.1235	EA	Brand	$0.0838	2026-08-19
00245531511KLOR-CON 8 MEQ TABLET	$0.1181	EA	Brand	$0.1020	2026-08-19
00245531501KLOR-CON 8 MEQ TABLET	$0.1181	EA	Brand	$0.1020	2026-08-19
00245531515KLOR-CON 8 MEQ TABLET	$0.1181	EA	Brand	$0.1020	2026-08-19

Showing 6 of 10 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$6.98

Highest Price

$42.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0506-01POTASSIUM CHLORIDE 10MEQ TAB,SA	$10.92	FSS	AvKare, LLC	06/14/2028
42291-0506-50POTASSIUM CHLORIDE 10MEQ TAB,SA	$42.95	FSS	AvKare, LLC	06/14/2028
00832-5323-11POTASSIUM CHLORIDE 10MEQ TAB,SA	$6.98	FSS	The Davinci Company, LLC	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Klor-Con (2024)

Total Spending

$9.7M

Total Claims

59,825

Beneficiaries

29,332

Avg Cost/Unit

$2.55

Spending Trend

$16.2M(2019)→$12.8M(2020)→$9.9M(2021)→$10.2M(2022)→$10.9M(2023)→$9.7M(2024)

YoY Change:-28.4%

5yr CAGR:-18.2%

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.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 3, 2018	SUPPL -36	View Letter (PDF)
Apr 20, 2006	SUPPL -24	View Letter (PDF)
May 27, 2004	SUPPL -22	View Letter (PDF)
Nov 25, 2003	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 8MEQ

RLDAB2

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 17, 1986

No patent or exclusivity listings for this strength.

#002 — 10MEQ

RLDAB2

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 17, 1986