Last Updated: November 8, 2026

Cyclophosphamide - Generic Drug Details

Name: cyclophosphamide Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for cyclophosphamide and what is the scope of freedom to operate?

Cyclophosphamide is the generic ingredient in six branded drugs marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Pharmazone, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Bedford, Teva Parenteral, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, Avyxa Holdings, and Roxane, and is included in thirty-one NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for cyclophosphamide

International Patents:	12
US Patents:	5
Tradenames:	6
Applicants:	24
NDAs:	31
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	4,365
Patent Applications:	7,558
Drug Prices:	Drug price trends for cyclophosphamide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cyclophosphamide
What excipients (inactive ingredients) are in cyclophosphamide?	cyclophosphamide excipients list
DailyMed Link:	cyclophosphamide at DailyMed

See drug prices for cyclophosphamide

Recent Clinical Trials for cyclophosphamide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St. Anna Children's Hospital, Vienna	PHASE1
University Hospital Tuebingen	PHASE1
Princess Maxima Center for Pediatric Oncology	PHASE1

See all cyclophosphamide clinical trials

Generic filers with tentative approvals for CYCLOPHOSPHAMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	2000MG/10ML	INJECTION;SOLUTION
⤷ Start Trial	⤷ Start Trial	500MG/2.5ML	INJECTION;SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for cyclophosphamide

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for cyclophosphamide

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CYCLOPHOSPHAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CYCLOPHOSPHAMIDE	Injection	cyclophosphamide	2 g/10 mL	212501	1	2023-01-17
CYCLOPHOSPHAMIDE	Injection	cyclophosphamide	500 mg/2.5 mL and 1 g/5 mL	212501	1	2022-03-07

US Patents and Regulatory Information for cyclophosphamide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Epic Pharma Llc	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	218644-001	Dec 19, 2024	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	040745-003	May 21, 2008	AP	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare	CYTOXAN	cyclophosphamide	TABLET;ORAL	012141-002	Approved Prior to Jan 1, 1982		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare	CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Nexus	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	216783-002	Oct 29, 2024	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Eirgen	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	218282-001	Dec 3, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cyclophosphamide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985	4,537,883	⤷ Start Trial
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-010	Sep 24, 1985	4,537,883	⤷ Start Trial
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-007	Dec 10, 1985	4,537,883	⤷ Start Trial
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-008	Jan 4, 1984	4,537,883	⤷ Start Trial
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-009	Dec 10, 1985	4,537,883	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for cyclophosphamide

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016005962		⤷ Start Trial
World Intellectual Property Organization (WIPO)	2016132270		⤷ Start Trial
Australia	2015256331	Formulations of Cyclophosphamide liquid concentrate	⤷ Start Trial
Brazil	112016026140	formulações de concentrado líquido de ciclofosfamida.	⤷ Start Trial
Canada	2948148	FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)	⤷ Start Trial
China	106456654	环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate)	⤷ Start Trial
European Patent Office	3139929	FORMULATIONS D'UN CONCENTRÉ LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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