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CYCLOPHOSPHAMIDE

NDA

CYCLOPHOSPHAMIDE | N210735 | EUGIA PHARMA SPECIALITIES LTD

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

9662342

Jun. 26, 2035

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AuroMedics Pharma LLC et al v. Ingenus Pharmaceuticals, LLC 1:2020cv01235	D. Del.	2020-09-16	Terminated 2021-10-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov, 170 active, 329 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia NCT03531736	Phase 1	Active	Memorial Sloan Kettering Cancer Center	17	2018-05-09 → 2026-05
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression NCT03480360	Phase 3	Active	Dartmouth-Hitchcock Medical Center	21	2018-03-28 → 2026-10-17
Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant NCT03247088	Phase 1/2	Active	M.D. Anderson Cancer Center	74	2017-07-30 → 2027-12-31
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma NCT02176967	Phase 3	Active	Children's Oncology Group	621	2014-08-08 → 2026-09-30
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1 NCT02650986	Phase 1/2	Active	Roswell Park Cancer Institute	15	2017-07-14 → 2032-07-14
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia NCT00792948	Phase 2	Active	National Cancer Institute (NCI)	97	2009-09-01 → 2027-01-06
Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara NCT03896737	Phase 2	Active	Stichting European Myeloma Network	401	2019-04-16 → 2028-02-01
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.NCT03225417	Phase 1/2	Active	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	142	2017-05-16 → 2024-12-31
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid NCT03295383	Phase 3	Active	University Hospital, Rouen	92	2019-07-11 → 2027-03
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers NCT03935893	Phase 2	Active	Udai Kammula	20	2019-12-03 → 2038-06-30

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

API Supply Chain16 active DMFs11 inactive

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

BAXTER HEALTHCARE CORPCYCLOPHOSPHAMIDE, USP/EP

DMF 35941979

BAXTER ONCOLOGY GMBHCYCLOPHOSPHAMIDE INJECTION VIALS

DMF 37161980

ZHEJIANG HISUN PHARMACEUTICAL CO LTDCYCLOPHOSPHAMIDE USP

DMF 151782000

JIANGSU HENGRUI PHARMACEUTICALS CO LTDCYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE

DMF 260412012

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

2 letters from Drugs@FDA

Date	Submission	Document
Nov 21, 2023	SUPPL -2	View Letter (PDF)
Aug 27, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 500MG/2.5ML (200MG/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 25, 2021

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9662342	Jun 26, 2035	—	—	Yes	—	—

#002 — 1GM/5ML (200MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 25, 2021

#003 — 2GM/10ML (200MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 20, 2023