Viewing data from:

ELMIRON

NDA

PENTOSAN POLYSULFATE SODIUM | N020193 | JANSSEN 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 Elmiron (2023)

Total Spending

$55.3M

Total Claims

46,533

Beneficiaries

9,394

Avg Cost/Unit

$11.27

Spending Trend

$99.3M(2019)→$83.5M(2020)→$63.4M(2021)→$58.4M(2022)→$55.3M(2023)

YoY Change:+7.5%

5yr CAGR:+5.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

BENE PHARMACHEM GMBH AND CO KGPENTOSAN POLYSULFATE SODIUM (PPS), NON-STERILE BULK DRUG SUBSTANCE

DMF 212482008

PURE AND CURE HEALTHCARE PRIVATE LTDPENTOSAN POLYSULFATE SODIUM

DMF 250112011

SWATI SPENTOSE PRIVATE LTDPENTOSAN POLYSULFATE SODIUM

DMF 258272012

MATRIX PHARMACORP PRIVATE LTDPENTOSAN POLYSULFATE SODIUM

DMF 312082017

ARAGEN LIFE SCIENCES LTDPENTOSAN POLYSULFATE SODIUM

DMF 340952019

MICRO LABS LTDPENTOSAN POLYSULFATE SODIUM

DMF 382942023

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)PENTOSAN POLYSULFATE SODIUM

DMF 425692025

ALEMBIC PHARMACEUTICALS LTDInactivePENTOSAN POLYSULFATE SODIUM

DMF 225822009

CF PHARMA LTDInactivePENTOSAN POLYSULFATE SODIUM

DMF 227812009

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 16, 2021	SUPPL -15	View Letter (PDF)
Jun 17, 2020	SUPPL -14	View Letter (PDF)
Dec 23, 2008	SUPPL -9	View Letter (PDF)
Jul 29, 2008	SUPPL -7	View Letter (PDF)
Sep 25, 2006	SUPPL -4	View Letter (PDF)
Aug 25, 2004	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 26, 1996

No patent or exclusivity listings for this strength.