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Last Updated: March 29, 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-three 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
James Michael MartinPhase 1
Affimed GmbHPhase 2
Artiva Biotherapeutics, Inc.Phase 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
Amneal CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 210046-003 May 25, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 088371-001 Jul 3, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 216958-003 Dec 18, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences CYCLOPHOSPHAMIDE cyclophosphamide CAPSULE;ORAL 211552-001 Dec 13, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-001 Feb 16, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-004 Aug 30, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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

International Patents for cyclophosphamide

Country Patent Number Title Estimated Expiration
Japan 2017514924 シクロホスファミド液状濃縮物の製剤 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2015171460 ⤷  Try a Trial
China 106456654 环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate) ⤷  Try a Trial
Canada 2948148 FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016005962 ⤷  Try a Trial
Japan 6516831 ⤷  Try a Trial
Brazil 112016026140 formulações de concentrado líquido de ciclofosfamida. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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