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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
UBS
Harvard Business School
Mallinckrodt
Dow
Covington
Chinese Patent Office
Deloitte
Johnson and Johnson

Generated: February 21, 2018

DrugPatentWatch Database Preview

Romidepsin - Generic Drug Details

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What are the generic drug sources for romidepsin and what is the scope of romidepsin freedom to operate?

Romidepsin
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Romidepsin has five patent family members in five countries.

There are two drug master file entries for romidepsin. Two suppliers are listed for this compound.
Summary for romidepsin

US Patents and Regulatory Information for romidepsin

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 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

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Expired US Patents for romidepsin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for romidepsin

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 ➤ Sign Up
9,371,361 Method of producing FR901228 ➤ Sign Up
8,426,556 Method of producing FR901228 ➤ Sign Up
8,445,634 Method of producing FR901228 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chubb
Cerilliant
Daiichi Sankyo
QuintilesIMS
Boehringer Ingelheim
Baxter
Julphar
Fuji

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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