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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Sodium Polystyrene Sulfonate* (2023)

Total Spending

$3.3M

Total Claims

50,006

Beneficiaries

29,272

Avg Cost/Unit

$0.21

Spending Trend

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

YoY Change:+5.1%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2023). 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

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#001 — 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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