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K-TAB

NDA

POTASSIUM CHLORIDE | N018279 | ABBVIE INC

3 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

5 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Granules India Limited FDA-2023-P-2339 · 7 docket documents Granules India Limited filed this citizen petition under 21 CFR 10.25, 10.30, and sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq, NDA No. 018279, held by ABBVIE INC, was withdrawn for safety or	505(q)	2023-06-08	Granted	Granules India Limited
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-2005 · 6 docket documents The law firm Hyman, Phelps & McNamara filed a suitability petition under 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, with K-TAB (po	Suitability	2020-09-23	Granted	HYMAN, PHELPS & MCNAMARA, P.C.
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	Denied	Lachman Consultant Services, Inc.
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2014-P-1657 · 4 docket documents Gordon Johnston Regulatory Consultants LLC filed this citizen petition on October 17, 2014, requesting that the FDA designate K-Tab potassium chloride extended-release tablets 20 mEq (Abbvie Inc., NDA 18279) as a second reference listed drug in the Orange Book to enable ANDA submissions by other spo	Other	2014-10-20	Granted	Gordon Johnston Regulatory Consultants LLC
Citizen Petition From Hyman, Phelps & McNamara , P.C. FDA-2014-P-0328 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA designate K-Tab (potassium chloride extended release tablets, USP, 20 meq., NDA No. 18279) as a Reference Listed Drug in the Orange Book to allow generic applicants to submit ANDAs referencing this product, since the curr	505(q)	2014-03-28	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

3 letters from Drugs@FDA

Date	Submission	Document
May 3, 2018	SUPPL -37	View Letter (PDF)
Feb 17, 2012	SUPPL -29	View Letter (PDF)
Dec 30, 2004	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 1, 1988

#003 — 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 25, 2013