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Serving leading biopharmaceutical companies globally:

Cipla
Queensland Health
Boehringer Ingelheim
US Department of Justice
Farmers Insurance
McKesson
Daiichi Sankyo
Colorcon
Cantor Fitzgerald
Julphar

Generated: February 24, 2018

DrugPatentWatch Database Preview

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 two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
Summary for ISTODAX
International Patents:5
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 42
Clinical Trials: 38
Patent Applications: 177
Drug Prices:see details
DailyMed Link:ISTODAX at DailyMed
Drug patent expirations by year for ISTODAX

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;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Paragraph IV (Patent) Challenges for ISTODAX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 10 mg/vial ➤ Subscribe 11/5/2013

Non-Orange Book US Patents for ISTODAX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,396,665 Method of producing FR901228 ➤ Try a Free Trial
9,371,361 Method of producing FR901228 ➤ Try a Free Trial
8,426,556 Method of producing FR901228 ➤ Try a Free Trial
8,445,634 Method of producing FR901228 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Julphar
McKesson
Express Scripts
Chubb
Daiichi Sankyo
Fish and Richardson
Deloitte
Citi

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 verifification 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.

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