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Last Updated: April 20, 2024

Cyclophosphamide - Generic Drug Details

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What are the generic 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, Anima, Cipla, Hikma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Bedford, Teva Parenteral, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Ingenus Pharms Llc, 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:	3,860
Patent Applications:	7,430
Formulation / Manufacturing:	see details
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
James Michael Martin	Phase 1
Affimed GmbH	Phase 2
Artiva Biotherapeutics, Inc.	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

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
Sunny	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	215089-003	Oct 26, 2023	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare	CYTOXAN	cyclophosphamide	TABLET;ORAL	012141-002	Approved Prior to Jan 1, 1982		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-001	Jun 7, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	012142-008	Jan 4, 1984	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-007	Dec 10, 1985	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	6516831		⤷ Try a Trial
Russian Federation	2016147362	ПРЕПАРАТЫ ЖИДКОГО КОНЦЕТРАТА ЦИКЛОФОСФАМИДА	⤷ Try a Trial
China	106456654	环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.