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MONUROL

NDA

FOSFOMYCIN TROMETHAMINE | N050717 | ZAMBON SPA ITALY

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prevention of Iron Deficiency Anemia Post-delivery NCT05590260	Phase 3	Completed	NICHD Global Network for Women's and Children's Health	4,857	2023-05-30 → 2025-07-28

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

Medicare Part D Spending

CMS annual spending data for Monurol (2023)

Total Spending

$79K

Total Claims

377

Beneficiaries

311

Avg Cost/Unit

$89.07

Spending Trend

$13.8M(2019)→$13.8M(2020)→$2.4M(2021)→$973K(2022)→$79K(2023)

YoY Change:-1.6%

5yr CAGR:-0.2%

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

API Supply Chain4 active DMFs

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

ERCROS SAFOSFOMYCIN TROMETHAMINE

DMF 311952017

QUIMICA SINTETICA SAFOSFOMYCIN TROMETHAMINE

DMF 332942018

HONOUR LAB LIMITEDFOSFOMYCIN TROMETHAMINE

DMF 403352024

MSN ORGANICS PRIVATE LTDFOSFOMYCIN TROMETHAMINE USP

DMF 404602024

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 15, 2018	SUPPL -10	View Letter (PDF)
Jun 1, 2018	SUPPL -9	View Letter (PDF)
Apr 13, 2011	SUPPL -7	View Letter (PDF)
Mar 13, 2008	SUPPL -5	View Letter (PDF)
Dec 18, 2002	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Dec 19, 1996

No patent or exclusivity listings for this strength.