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MICRO-K

NDA

POTASSIUM CHLORIDE | N018238 | NESHER PHARMACEUTICALS USA 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
Attachment 1 - Micro-K LS -Orange Book: Approved Drug Products with Therapeut... FDA-2020-P-2181 · 6 docket documents 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.

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

Clinical Trials

21 trials from ClinicalTrials.gov, 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
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
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults NCT00357214	N/A	Completed	Tufts University	171	2006-09 → 2008-04
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.

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

2 letters from Drugs@FDA

Date	Submission	Document
May 3, 2018	SUPPL -46	View Letter (PDF)
Aug 25, 2003	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 14, 1984