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Last Updated: July 21, 2024


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Which patents cover Cyclophosphamide, and when can generic versions of Cyclophosphamide launch?

Cyclophosphamide is a drug marketed by Alembic, Ani Pharms, Anima, Cipla, Hikma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Ingenus Pharms Llc, Sandoz, and Roxane. and is included in twenty-three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twelve patent family members in nine countries.

The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclophosphamide

A generic version of CYCLOPHOSPHAMIDE was approved as cyclophosphamide by BAXTER HLTHCARE on May 21st, 2008.

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Drug patent expirations by year for CYCLOPHOSPHAMIDE

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Recent Clinical Trials for CYCLOPHOSPHAMIDE

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

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

See all CYCLOPHOSPHAMIDE clinical trials

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

CYCLOPHOSPHAMIDE is protected by four US patents.

Patents protecting CYCLOPHOSPHAMIDE

Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable ready to use cyclophosphamide liquid formulations
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Formulations of cyclophosphamide liquid concentrate
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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
Dr Reddys CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210852-002 Jun 7, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sunny CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 215089-002 Oct 26, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ingenus Pharms Llc CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 212501-002 Jul 30, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Dr Reddys CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210852-001 Jun 7, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ingenus Pharms Llc CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 212501-003 Nov 19, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CYCLOPHOSPHAMIDE

See the table below for patents covering CYCLOPHOSPHAMIDE around the world.

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 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016132270 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2015171460 ⤷  Sign Up
China 106456654 环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate) ⤷  Sign Up
>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.