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Last Updated: July 13, 2024

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, 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-seven suppliers are listed for this compound.

Summary for cyclophosphamide
Drug Prices for cyclophosphamide

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Recent Clinical Trials for cyclophosphamide

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

SponsorPhase
The University of QueenslandPhase 3
University of AdelaidePhase 3
MSD FrancePhase 2

See all cyclophosphamide clinical trials

Pharmacology for cyclophosphamide
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hengrui Pharma CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 204555-001 Oct 31, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 217150-003 Sep 12, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CYCLOPHOSPHAMIDE cyclophosphamide CAPSULE;ORAL 203856-001 Sep 16, 2013 AB RX 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

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 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

Country Patent Number Title Estimated Expiration
Canada 2948148 FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016132270 ⤷  Sign Up
European Patent Office 3139929 FORMULATIONS D'UN CONCENTRÉ LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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