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Boehringer Ingelheim
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Last Updated: March 26, 2023


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

Cyclophosphamide is a drug marketed by Alembic Pharms, Ani Pharms, Anima, Cipla, Hikma, Amneal, Baxter Hlthcare, Hengrui Pharma, Xellia Pharms Aps, Eugia Pharma Speclts, Ingenus Pharms Llc, and Roxane. and is included in sixteen NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eleven patent family members in nine countries.

The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Seventeen 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

See drug prices for CYCLOPHOSPHAMIDE

Recent Clinical Trials for CYCLOPHOSPHAMIDE

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

James Michael MartinPhase 1
InvectysPhase 1/Phase 2
Anhui Provincial HospitalPhase 1

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 two US patents.

Patents protecting CYCLOPHOSPHAMIDE

Stable ready to use cyclophosphamide liquid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of cyclophosphamide liquid concentrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane CYCLOPHOSPHAMIDE cyclophosphamide TABLET;ORAL 040032-001 Aug 17, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma Speclts CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210735-001 Aug 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Roxane CYCLOPHOSPHAMIDE cyclophosphamide TABLET;ORAL 040032-002 Aug 17, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ingenus Pharms Llc CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 212501-002 Jul 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing
Australia 2015256331 Formulations of Cyclophosphamide liquid concentrate See Plans and Pricing
World Intellectual Property Organization (WIPO) 2015171460 See Plans and Pricing
Japan 6516831 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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.