Cyclophosphamide - Generic Drug Details

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

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, Nexus, Sandoz, and Roxane, and is included in twenty-eight 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:	21
NDAs:	28
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
The University of Queensland	Phase 3
University of Adelaide	Phase 3
Fred Hutchinson Cancer Center	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
Hikma	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	203856-002	Sep 16, 2013	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Kanchan Hlthcare	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	209872-001	May 7, 2018	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hikma	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	203856-001	Sep 16, 2013	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Teva Parenteral	NEOSAR	cyclophosphamide	INJECTABLE;INJECTION	040015-004	Apr 29, 1993		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Cipla	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	211608-002	Jan 18, 2019	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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	⤷ Subscribe	⤷ Subscribe
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985	⤷ Subscribe	⤷ Subscribe
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-007	Dec 10, 1985	⤷ Subscribe	⤷ Subscribe
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-008	Jan 4, 1984	⤷ Subscribe	⤷ Subscribe
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-009	Dec 10, 1985	⤷ Subscribe	⤷ Subscribe
>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
Brazil	112016026140	formulações de concentrado líquido de ciclofosfamida.	⤷ Subscribe
Canada	2948148	FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)	⤷ Subscribe
Australia	2015256331	Formulations of Cyclophosphamide liquid concentrate	⤷ Subscribe
China	106456654	环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate)	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2016132270		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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