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POTASSIUM CITRATE

NDA

POTASSIUM CITRATE | N019647 | UT SOUTHWESTERN MEDCTR

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

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Nomax, Inc. - Citizen Petition FDA-2013-P-0503 · 4 docket documents Nomax, Inc. filed this citizen petition on April 18, 2013, requesting that the FDA Commissioner determine whether the voluntary withdrawal of Urocit-K Powder (potassium citrate, NDA 019647) from commercial distribution by the University of Texas Southwestern Medical Center was for reasons other than	Other	2013-05-06	Granted	—
Nomax, Inc. - Citizen Petition FDA-2013-P-0506 · 3 docket documents Nomax, Inc. filed a suitability petition on April 18, 2013, requesting FDA approval to submit an ANDA for Effer-K, an effervescent tablet formulation of potassium citrate, in three strengths (10 meq, 20 meq, and 25 meq) as a generic equivalent to the reference listed drug Urocit-K Powder (NDA 019647	505(q)	2013-05-06	Open	—
Nomax, Inc. - Citizen Petition FDA-2013-P-0504 · 6 docket documents Nomax, Inc. filed this citizen petition on April 18, 2013, requesting that the FDA amend the Orange Book to designate Urocit-K Powder (potassium citrate, NDA 019647) as a reference listed drug product, distinguishing it from the currently designated Urocit-K 15 meq extended release tablets due to di	Other	2013-05-06	Denied	—
Immunotec, Inc. - Tab 1- Citizen Petition FDA-2007-P-0286 · 5 docket documents Dr. Wulf Dröge of Immunotec Inc. filed this petition on April 2, 2007, pursuant to section 403(r)(5)D of the Federal Food, Drug, and Cosmetic Act, requesting a health claim stating that alkaline and earth alkaline citrates including potassium citrate, sodium citrate, calcium citrate, and magnesium c	Other	2008-05-15	Open	—

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.

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVPOTASSIUM CITRATE USP

DMF 310682016

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM CITRATE USP

DMF 368752022

ARCHER DANIELS MIDLAND COInactivePOTASSIUM CITRATE MONOHYDRATE

DMF 103011993

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

Products (2)

Sort:

#001 — 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 13, 1988

No patent or exclusivity listings for this strength.

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

RLD

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 13, 1988