Viewing data from:

KAYEXALATE

NDA

SODIUM POLYSTYRENE SULFONATE | N011287 | CONCORDIA PHARMACEUTICALS INC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
KVK-Tech, Inc. - Citizen Petition FDA-2011-P-0913 · 4 docket documents KVK-Tech, Inc. filed a suitability petition under 21 CFR 314.93 on December 15, 2011, requesting approval to market Kalexate (sodium polystyrene sulfonate, USP) powder in a new 15 gram per bottle packaging presentation as a supplement to ANDA 40-905, which was previously approved for the 454 gram pe	Other	2011-12-28	Granted	—

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients NCT02065076	Phase 4	Completed	Maisonneuve-Rosemont Hospital	38	2014-02 → 2014-10
Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia NCT01866709	Phase 4	Terminated	ZS Pharma, Inc.	32	2013-05 → 2013-08

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

Medicare Part D Spending

CMS annual spending data for Sodium Polystyrene Sulfonate (2024)

Total Spending

$3.0M

Total Claims

50,770

Beneficiaries

29,098

Avg Cost/Unit

$0.18

Spending Trend

$5.0M(2019)→$4.3M(2020)→$3.6M(2021)→$3.4M(2022)→$3.3M(2023)→$3.0M(2024)

YoY Change:-12.1%

5yr CAGR:-2.4%

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

API Supply Chain2 active DMFs

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

PUROLITE LLCSODIUM POLYSTYRENE SULFONATE

DMF 58821985

ION EXCHANGE INDIA LTDSODIUM POLYSTYRENE SULFONATE USP (INDION 254)

DMF 183642005

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2017	SUPPL -26	View Letter (PDF)
Jan 5, 2011	SUPPL -23	View Letter (PDF)
Nov 19, 2009	SUPPL -22	View Letter (PDF)
May 4, 2009	SUPPL -21	View Letter (PDF)
Dec 11, 2003	SUPPL -18	View Letter (PDF)
Jun 8, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;ORAL, RECTAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.