Cyclophosphamide - Generic Drug Details

✉ Email this page to a colleague

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-five suppliers are listed for this compound. There is one tentative approval 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:	25
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,948
Patent Applications:	7,510
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
National Cord Blood Network	Phase 2

See all cyclophosphamide clinical trials

Generic filers with tentative approvals for CYCLOPHOSPHAMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1G/5ML(200MG/ML)	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	500MG/2.5ML(200MG/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	215089-002	Oct 26, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	214529-002	Jul 17, 2023	AP	RX	No	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
Bedford	NEOSAR	cyclophosphamide	INJECTABLE;INJECTION	087442-005	Mar 30, 1989		DISCN	No	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

Subscribe to access the full database, or Sign Up
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	012142-007	Dec 10, 1985	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-008	Jan 4, 1984	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-009	Dec 10, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for cyclophosphamide

Subscribe to access the full database, or Sign Up
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
Brazil	112016026140	formulações de concentrado líquido de ciclofosfamida.	⤷ Sign Up
Australia	2015256331	Formulations of Cyclophosphamide liquid concentrate	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015171460		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.