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Last Updated: June 22, 2021

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ISTODAX Drug Profile

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When do Istodax patents expire, and when can generic versions of Istodax launch?

Istodax is a drug marketed by Celgene and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in five countries.

The generic ingredient in ISTODAX is romidepsin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Istodax

A generic version of ISTODAX was approved as romidepsin by TEVA PHARMS USA INC on March 13th, 2020.

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Drug patent expirations by year for ISTODAX
Drug Prices for ISTODAX

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Recent Clinical Trials for ISTODAX

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

Ohio State University Comprehensive Cancer CenterPhase 1
AstraZenecaPhase 1/Phase 2
GWT-TUD GmbHPhase 1/Phase 2

See all ISTODAX clinical trials

Paragraph IV (Patent) Challenges for ISTODAX
Tradename Dosage Ingredient NDA Submissiondate
ISTODAX POWDER;INTRAVENOUS romidepsin 022393 2013-11-05

US Patents and Regulatory Information for ISTODAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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