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MESNEX

NDA

MESNA | N020855 | 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

146 trials from ClinicalTrials.gov — 5 recruiting, 13 active, 82 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies NCT01652092	N/A	Active	Masonic Cancer Center, University of Minnesota	57	2012-09-04 → 2026-12
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma NCT01864109	Phase 2	Active	Memorial Sloan Kettering Cancer Center	83	2013-05 → 2027-05
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation NCT02790515	Phase 2	Active	St. Jude Children's Research Hospital	170	2016-07-14 → 2026-07-01
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation NCT03663933	Phase 2	Active	National Cancer Institute (NCI)	71	2018-09-04 → 2030-04-03
Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia NCT03573700	Phase 1/2	Active	St. Jude Children's Research Hospital	24	2018-07-24 → 2026-07-01
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors NCT01873326	Phase 2	Active	Memorial Sloan Kettering Cancer Center	92	2013-06 → 2026-06
Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma NCT01783535	Phase 2	Active	St. Jude Children's Research Hospital	174	2013-06-19 → 2027-02-21
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma NCT02436707	Phase 2	Active	Canadian Cancer Trials Group	129	2015-10-27 → 2026-12-31
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies NCT03849651	Phase 2	Active	St. Jude Children's Research Hospital	69	2019-01-31 → 2026-06-07
Liver Transplantation With Tregs at MGH NCT03577431	Phase 1/2	Active	National Institute of Allergy and Infectious Diseases (NIAID)	9	2019-03-29 → 2027-04-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$500.37

Highest Price

$500.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67108-3565-09MESNEX 400MG TAB	$500.37	FSS	Baxter Healthcare Corporation	08/14/2026

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

API Supply Chain5 active DMFs5 inactive

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

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMESNA USP

DMF 162552002

AARTI PHARMALABS LTDMESNA

DMF 226642009

BAXTER HEALTHCARE CORPMESNA, USP/EP DRUG SUBSTANCE

DMF 252762011

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 -3	View Letter (PDF)
Mar 19, 2014	SUPPL -2	View Letter (PDF)
Jan 10, 2013	SUPPL -1	View Letter (PDF)
May 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 21, 2002

No patent or exclusivity listings for this strength.