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CYTOXAN

NDA

CYCLOPHOSPHAMIDE | N012141 | BAXTER HEALTHCARE CORP

2 strengths0 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

4 trials from ClinicalTrials.gov — 4 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus NCT06518668	Phase 1	By Invitation	Hospital for Special Surgery, New York	6	2024-07-01 → 2040-12
Immune Modulatory DC Vaccine Against Brain Tumor NCT03914768	Phase 1	By Invitation	Shenzhen Geno-Immune Medical Institute	10	2026-05-31 → 2029-12-31
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors NCT05269381	Phase 1/2	Recruiting	Mayo Clinic	132	2022-03-31 → 2028-03-31
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis NCT03520647	Phase 2	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	56	2019-02-19 → 2028-06-01

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

Medicare Part D Spending

CMS annual spending data for Cyclophosphamide* (2023)

Total Spending

$2.7M

Total Claims

5,645

Beneficiaries

1,621

Avg Cost/Unit

$101.29

Spending Trend

$3.8M(2019)→$3.3M(2020)→$2.9M(2021)→$3.0M(2022)→$2.7M(2023)

YoY Change:+5.4%

5yr CAGR:+2.4%

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

API Supply Chain14 active DMFs11 inactive

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

BAXTER ONCOLOGY GMBHCYCLOPHOSPHAMIDE INJECTION VIALS

DMF 37161980

ZHEJIANG HISUN PHARMACEUTICAL CO LTDCYCLOPHOSPHAMIDE USP

DMF 151782000

HETERO LABS LTDCYCLOPHOSPHAMIDE MONOHYDRATE, USP

DMF 267532012

EMCURE PHARMACEUTICALS LTDCYCLOPHOSPHAMIDE USP

DMF 298392015

MSN LABORATORIES PRIVATE LTDCYCLOPHOSPHAMIDE MONOHYDRATE USP

DMF 310882016

AMPAC FINE CHEMICALS LLCCYCLOPHOSPHAMIDE MONOHYDRATE

DMF 324922018

SUNNY PHARMTECH INCCYCLOPHOSPHAMIDE USP

DMF 332912019

SHILPA PHARMA LIFESCIENCES LTDCYCLOPHOSPHAMIDE USP

DMF 340662019

AARTI PHARMALABS LTDCYCLOPHOSPHAMIDE STERILE USP

DMF 353132021

NAVINTA LLCCYCLOPHOSPHAMIDE USP (STERILE)

DMF 359752021

APICORE LLCCYCLOPHOSPHAMIDE USP (STERILE BULK)

DMF 360892021

AARTI PHARMALABS LTDCYCLOPHOSPHAMIDE

DMF 370862022

ANHUI POLY PHARM CO LTDCYCLOPHOSPHAMIDE USP

DMF 371542022

NAVINTA LLCCYCLOPHOSPHAMIDE USP

DMF 382322023

FERMION OYInactiveCYCLOPHOSPHAMIDE ORAL GRADE

DMF 32721978

ASTA WERKE AKTIENGESELLSCHAFTInactiveCYCLOPHOSPHAMIDE TABLETS

DMF 47241982

ORION CORPInactiveCYCLOPHOSPHAMIDE 50 MG TABLETS

DMF 52981984

BEN VENUE LABORATORIES INCInactiveCYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5 DOSAGE FORMS)BEDFORD,OHIO FAC

DMF 55411984

PHARM ECO LABORATORIES INCInactiveCYCLOPHOSPHAMIDE MONOHYDRATE

DMF 63981985

ORION CORP FARMOS CHEMICAL PLANTInactiveCYCLOPHOSPHAMIDE 50 MG. TABL.

DMF 73411988

LIANYUNGANG PHARMACEUTICAL FACTORYInactiveCYCLOPHOSPHAMIDE USP,NON-STERILE BULK DRUG

DMF 130501998

DEGUSSA HULS AGInactiveCYCLOPHOSPHAMIDE

DMF 148302000

OLAINFARM JOINT STOCK COInactiveCYCLOPHOSPHAMIDE

DMF 170652003

EMCURE PHARMACEUTICALS LTDInactiveCYCLOPHOSPHAMIDE USP

DMF 227942009

SUNNY PHARMTECH INCInactiveCYCLOPHOSPHAMIDE

DMF 261372012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2020	SUPPL -91	View Letter (PDF)
May 10, 2013	SUPPL -90	View Letter (PDF)
Apr 4, 2012	SUPPL -89	View Letter (PDF)
Mar 10, 2003	SUPPL -87	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982