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CYCLOPHOSPHAMIDE

NDA

CYCLOPHOSPHAMIDE | N212501 | DR REDDYS LABORATORIES INC

3 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

10993952

Feb. 15, 2036

12329767

Feb. 15, 2036

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Ingenus Pharmaceuticals, LLC v. Hetero USA, Inc. et al 1:2024cv01025 1 patentANDA 219271cyclophosphamide	D. Del.	2024-09-11	Terminated 2025-10-21	—
Ingenus Pharmaceuticals, LLC et al v. Accord Healthcare, Inc. 1:2023cv00377 1 patentANDA 218250cyclophosphamide	D. Del.	2023-04-03	Terminated 2025-04-01	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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
Mar 13, 2025	SUPPL -7	View Letter (PDF)
Jun 26, 2024	SUPPL -3	View Letter (PDF)
Sep 13, 2021	SUPPL -2	View Letter (PDF)
Aug 5, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 500MG/2.5ML (200MG/ML)

RLDAP

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 30, 2020

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10993952	Feb 15, 2036	—	—	Yes	—	—
12329767	Feb 15, 2036	—	—	Yes	—	—

#002 — 1GM/5ML (200MG/ML)

RLDAP

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 30, 2020

#003 — 2GM/10ML (200MG/ML)

RLD

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 19, 2021