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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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Jill H. Osborne FDA-2018-P-4306 · 4 docket documents Jill H. Osborne, founder of the Interstitial Cystitis Network, filed this citizen petition on November 8, 2018, requesting that the FDA issue an alert to patients taking pentosan polysulfate (Elmiron) regarding associations between long-term use and retinal disease, including annual eye examinations	Other	2018-11-09	Partially Denied	Jill H. Osborne
Janssen Pharmaceuticals, Inc (Ropes & Gray LLP) - Citizen Petition FDA-2012-P-0295 · 3 docket documents Janssen Pharmaceuticals, Inc., filed this citizen petition under section 505(q) requesting that the FDA establish appropriate bioequivalence requirements for any abbreviated new drug application (ANDA) seeking to reference ELMIRON (pentosan polysulfate sodium) as the reference listed drug. Janssen a	505(q)	2012-04-23	Withdrawn	—

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

Clinical Trials

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland NCT00236990	Phase 2	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	283	— → 2005-09
Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy NCT00003825	Phase 3	Completed	Radiation Therapy Oncology Group	174	1999-06
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders NCT02930005	Phase 2	Completed	The University of Texas Health Science Center, Houston	8	2015-08-07 → 2016-10-06
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis NCT00086684	Phase 4	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	369	2003-09 → 2011-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$12.10

per ea

Lowest NADAC/Unit

$12.10

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50458009801ELMIRON 100 MG CAPSULE	$12.10	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$851.63

Highest Price

$1157.91

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50458-0098-01ELMIRON 100MG CAP	$1157.91	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0098-01ELMIRON 100MG CAP	$851.63	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Elmiron (2024)

Total Spending

$52.0M

Total Claims

42,953

Beneficiaries

9,098

Avg Cost/Unit

$11.01

Spending Trend

$99.3M(2019)→$83.5M(2020)→$63.4M(2021)→$58.4M(2022)→$55.3M(2023)→$52.0M(2024)

YoY Change:-2.3%

5yr CAGR:+4.0%

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

API Supply Chain8 active DMFs2 inactive

8 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

DR REDDYS LABORATORIES LTDPENTOSAN POLYSULFATE SODIUM

DMF 432472026

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.