Is there a generic for Cyclophosphamide?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Cyclophosphamide, referencing the brand CYCLOPHOSPHAMIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cyclophosphamide?

CYCLOPHOSPHAMIDE (NDA 217150, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Cyclophosphamide?

The Orange Book lists 5 patents against Cyclophosphamide products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Cyclophosphamide are approved?

Cyclophosphamide is approved in the following dosage forms: capsule, injectable, solution, tablet.

FDA Orange Book · active-ingredient family

Cyclophosphamide

Cyclophosphamide is approved as 8 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYCLOPHOSPHAMIDE · NDA 217150

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, injectable, solution, tablet

Product	Applicant	Application	TE	Approved
CYCLOPHOSPHAMIDERLD×3	SANDOZ	NDA 217150	—	Sep 12, 2023
CYCLOPHOSPHAMIDERLD×2	BAXTER HLTHCARE CORP	NDA 217651	—	Jun 28, 2023
FRINDOVYXRLD×3	AVYXA HOLDINGS	NDA 210852	—	Jun 07, 2023
CYCLOPHOSPHAMIDERLD×3	EUGIA PHARMA SPECLTS	NDA 210735	—	Aug 25, 2021
CYCLOPHOSPHAMIDERLD×3	DR REDDYS	NDA 212501	AP	Jul 30, 2020
CYCLOPHOSPHAMIDERLD×2	HIKMA	NDA 203856	AB	Sep 16, 2013
CYTOXANRLD×10	BAXTER HLTHCARE	NDA 012142	—	Approved Prior to Jan 1, 1982
CYTOXANRLD×2	BAXTER HLTHCARE	NDA 012141	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (23)

Product	Applicant	Application	TE	Approved
CYCLOPHOSPHAMIDE×3	HAINAN POLY	ANDA 218632	—	Dec 26, 2024
CYCLOPHOSPHAMIDE×3	EPIC PHARMA LLC	ANDA 218644	AP	Dec 19, 2024
CYCLOPHOSPHAMIDE×2	EIRGEN	ANDA 218282	AB	Dec 03, 2024
CYCLOPHOSPHAMIDE×2	NEXUS	ANDA 216783	AP	Oct 29, 2024
CYCLOPHOSPHAMIDE×3	HIKMA	ANDA 216958	AP	Dec 18, 2023
CYCLOPHOSPHAMIDE×2	ZYDUS LIFESCIENCES	ANDA 211552	AB	Dec 13, 2023
CYCLOPHOSPHAMIDE×3	SUNNY	ANDA 215089	AP	Oct 26, 2023
CYCLOPHOSPHAMIDE×3	SAGENT PHARMS INC	ANDA 214529	AP	Jul 17, 2023
CYCLOPHOSPHAMIDE×2	ALEMBIC	ANDA 215892	AB	Nov 10, 2022
CYCLOPHOSPHAMIDE×3	XGEN PHARMS	ANDA 211757	AP	Oct 18, 2022
CYCLOPHOSPHAMIDE×2	CIPLA	ANDA 211608	AB	Jan 18, 2019
CYCLOPHOSPHAMIDE×3	AMNEAL	ANDA 210046	AP	May 25, 2018
CYCLOPHOSPHAMIDE×2	SENORES PHARMS	ANDA 209872	AB	May 07, 2018
CYCLOPHOSPHAMIDE×2	ANI PHARMS	ANDA 207014	—	Mar 19, 2018
CYCLOPHOSPHAMIDE×3	HENGRUI PHARMA	ANDA 204555	AP	Oct 31, 2014
CYCLOPHOSPHAMIDE×3	BAXTER HLTHCARE	ANDA 040745	AP	May 21, 2008
CYCLOPHOSPHAMIDE×2	ROXANE	ANDA 040032	—	Aug 17, 1999
NEOSAR×5	TEVA PARENTERAL	ANDA 040015	—	Apr 29, 1993
CYCLOPHOSPHAMIDE	BAXTER HLTHCARE	ANDA 088374	—	Sep 24, 1986
CYCLOPHOSPHAMIDE	BAXTER HLTHCARE	ANDA 088371	—	Jul 03, 1986
CYCLOPHOSPHAMIDE	BAXTER HLTHCARE	ANDA 088372	—	Jul 03, 1986
CYCLOPHOSPHAMIDE	BAXTER HLTHCARE	ANDA 088373	—	Jul 03, 1986
NEOSAR×5	BEDFORD	ANDA 087442	—	Jul 08, 1983

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9662342	Jun 26, 2035	in 9 yr 2 mo	Product
10849916	Jul 13, 2035	in 9 yr 2 mo	Product
11382923	Dec 01, 2035	in 9 yr 7 mo	Product
10993952	Feb 15, 2036	in 9 yr 10 mo	Product
12329767	Feb 15, 2036	in 9 yr 10 mo	Product

Cyclophosphamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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