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MESNEX

NDA

MESNA | N019884 | BAXTER HEALTHCARE CORP

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
Citizen Petition from Gland Pharma Limited FDA-2015-P-4237 Gland Pharma Limited filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Mesna Injection, 20 mg/mL in a 50 mL IV infusion bag suitable for submission as an abbreviated new drug application, with the r	Other	2015-11-18	Denied	Gland Pharma Limited

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

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer NCT03412877	Phase 2	Recruiting	National Cancer Institute (NCI)	285	2018-09-06 → 2029-03-23
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer NCT01174121	Phase 2	Recruiting	National Cancer Institute (NCI)	332	2010-08-26 → 2029-12-27

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

Medicare Part D Spending

CMS annual spending data for Mesnex* (2023)

Total Spending

$708K

Total Claims

643

Beneficiaries

284

Avg Cost/Unit

$83.48

Spending Trend

$525K(2019)→$596K(2020)→$545K(2021)→$659K(2022)→$708K(2023)

YoY Change:+2.0%

5yr CAGR:+1.1%

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

API Supply Chain4 active DMFs5 inactive

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

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMESNA USP

DMF 162552002

AARTI PHARMALABS LTDMESNA

DMF 226642009

SOLARA ACTIVE PHARMA SCIENCES LTDMESNA

DMF 295222015

SUZHOU RYWAY BIOTECH CO LTDMESNA

DMF 424242025

UCB PHARMA SAInactiveMESNA

DMF 38801980

ASTA WERKE AKTIENGESELLSCHAFTInactiveMESNA AMPOULES

DMF 53051984

LIANYUNGANG PHARMACEUTICAL FACTORYInactiveMESNA

DMF 120721996

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveMESNA

DMF 147322000

JIANGSU HENGRUI MEDICINE CO LTDInactiveMESNA USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 260372012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -16	View Letter (PDF)
Mar 19, 2014	SUPPL -13	View Letter (PDF)
Jan 30, 2003	SUPPL -8	View Letter (PDF)
Jan 30, 2003	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Dec 30, 1988

No patent or exclusivity listings for this strength.