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Last Updated: July 10, 2020

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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 Ani Pharms Inc, Cipla, Hikma, Sti Pharma Llc, Amneal, Baxter Hlthcare, Jiangsu Hengrui Med, Bedford, Teva Parenteral, and Roxane, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for cyclophosphamide. Nine suppliers are listed for this compound.

Drug Prices for cyclophosphamide

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Recent Clinical Trials for cyclophosphamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Radboud UniversityPhase 1/Phase 2
Brooklyn ImmunoTherapeutics, LLCPhase 2
City of Hope Medical CenterEarly Phase 1

See all cyclophosphamide clinical trials

Pharmacology for cyclophosphamide
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for CYCLOPHOSPHAMIDE
Tradename Dosage Ingredient NDA Submissiondate
CYTOXAN (LYOPHILIZED) INJECTABLE;INJECTION cyclophosphamide 012142
LYOPHILIZED CYTOXAN INJECTABLE;INJECTION cyclophosphamide 012142
CYTOXAN INJECTABLE;INJECTION cyclophosphamide 012142

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
Teva Parenteral NEOSAR cyclophosphamide INJECTABLE;INJECTION 040015-003 Apr 29, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-003 Feb 16, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla CYCLOPHOSPHAMIDE cyclophosphamide CAPSULE;ORAL 211608-002 Jan 18, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 040745-003 May 21, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
Baxter Hlthcare CYTOXAN cyclophosphamide TABLET;ORAL 012141-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-001 Feb 16, 1982 DISCN No No   Start Trial   Start Trial   Start 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

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Boehringer Ingelheim
McKinsey
Harvard Business School
Dow

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