cyclophosphamide - Profile

What are the generic drug sources for cyclophosphamide and what is the scope of patent protection?

Cyclophosphamide is the generic ingredient in six branded drugs marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Senores Pharms, 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.

Cyclophosphamide has twelve patent family members in nine countries.

There is one tentative approval for this compound.

Summary for cyclophosphamide

International Patents:	12
US Patents:	5
Tradenames:	6
Applicants:	24
NDAs:	31
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cyclophosphamide

Generic filers with tentative approvals for CYCLOPHOSPHAMIDE

Applicant	Application No.	Strength	Dosage Form
		2000MG/10ML	INJECTION;SOLUTION
		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.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	215892-001	Nov 10, 2022	AB	RX	No	No
Alembic	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	215892-002	Nov 10, 2022	AB	RX	No	No
Ani Pharms	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	207014-001	Mar 19, 2018		DISCN	No	No
Ani Pharms	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	207014-002	Mar 19, 2018		DISCN	No	No
Cipla	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	211608-001	Jan 18, 2019	AB	RX	No	No
Cipla	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	211608-002	Jan 18, 2019	AB	RX	No	No

Expired US Patents for cyclophosphamide

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

International Patents for cyclophosphamide

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