➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Merck
Baxter
McKinsey

Last Updated: July 5, 2020

DrugPatentWatch Database Preview

ISTODAX Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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. Three suppliers are listed for this compound. Additional details are available on the romidepsin profile page.

US ANDA 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.

  Start Trial

Drug patent expirations by year for ISTODAX
Drug Prices for ISTODAX

See drug prices for ISTODAX

Recent Clinical Trials for ISTODAX

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

SponsorPhase
AstraZenecaPhase 1/Phase 2
GWT-TUD GmbHPhase 1/Phase 2
BayerPhase 1

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Merck
Baxter
McKinsey

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.