Cyclophosphamide - Generic Drug Details

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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 five branded drugs marketed by Alembic, Ani Pharms, Cipla, Hikma, Kanchan Hlthcare, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Bedford, Teva Parenteral, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Sandoz, and Roxane, and is included in twenty-seven NDAs. There are four 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 are nineteen drug master file entries for cyclophosphamide. Twenty-four suppliers are listed for this compound.

Summary for cyclophosphamide

International Patents:	12
US Patents:	4
Tradenames:	5
Applicants:	20
NDAs:	27
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,948
Patent Applications:	7,451
Drug Prices:	Drug price trends 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
University of Adelaide	Phase 3
The University of Queensland	Phase 3
National Cord Blood Network	Phase 2

See all cyclophosphamide clinical trials

Pharmacology for cyclophosphamide

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

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	CYTOXAN	cyclophosphamide	TABLET;ORAL	012141-002	Approved Prior to Jan 1, 1982		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	211552-001	Dec 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-001	Approved Prior to Jan 1, 1982		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

Expired US Patents for cyclophosphamide

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

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