CYCLOPHOSPHAMIDE Drug Patent Profile

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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:	4,429
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
National Cord Blood Network	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.

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Stable ready to use cyclophosphamide liquid formulations
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Formulations of cyclophosphamide liquid concentrate
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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
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
>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.

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2016147362	ПРЕПАРАТЫ ЖИДКОГО КОНЦЕТРАТА ЦИКЛОФОСФАМИДА	⤷ Sign Up
Australia	2015256331	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
>Country	>Patent Number	>Title	>Estimated Expiration