CYCLOPHOSPHAMIDE Drug Patent Profile

✉ Email this page to a colleague

Cyclophosphamide is a drug marketed by Alembic, Ani Pharms, Cipla, Hikma, Kanchan Hlthcare, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Sandoz, and Roxane. and is included in twenty-three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twelve patent family members in nine countries.

The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

A generic version of CYCLOPHOSPHAMIDE was approved as cyclophosphamide by BAXTER HLTHCARE on May 21^st, 2008.

International Patents:	12
US Patents:	4
Applicants:	18
NDAs:	23
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,948
Patent Applications:	4,452
Drug Prices:	Drug price information for CYCLOPHOSPHAMIDE
What excipients (inactive ingredients) are in CYCLOPHOSPHAMIDE?	CYCLOPHOSPHAMIDE excipients list
DailyMed Link:	CYCLOPHOSPHAMIDE at DailyMed

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

Sponsor	Phase
The University of Queensland	Phase 3
University of Adelaide	Phase 3
Fred Hutchinson Cancer Center	Phase 2

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

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

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

CYCLOPHOSPHAMIDE is protected by four US patents.

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Stable ready to use cyclophosphamide liquid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of cyclophosphamide liquid concentrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sunny	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	215089-002	Oct 26, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210735-002	Aug 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Baxter Hlthcare Corp	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	217651-001	Jun 28, 2023		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210735-003	Nov 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Roxane	CYCLOPHOSPHAMIDE	cyclophosphamide	TABLET;ORAL	040032-001	Aug 17, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	216958-001	Dec 18, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

See the table below for patents covering CYCLOPHOSPHAMIDE around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	106456654	环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate)	⤷ Sign Up
Russian Federation	2016147362	ПРЕПАРАТЫ ЖИДКОГО КОНЦЕТРАТА ЦИКЛОФОСФАМИДА	⤷ Sign Up
South Korea	20170008252	사이클로포스파미드 액상 농축 제제 (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)	⤷ Sign Up
Canada	2948148	FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)	⤷ Sign Up
Japan	6516831		⤷ Sign Up
Australia	2015256331	Formulations of Cyclophosphamide liquid concentrate	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015171460		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration