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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022393

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NDA 022393 describes ISTODAX, which is a drug marketed by Celgene and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ISTODAX profile page.

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 022393
Tradename:ISTODAX
Applicant:Celgene
Ingredient:romidepsin
Patents:2
Suppliers and Packaging for NDA: 022393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISTODAX romidepsin POWDER;IV (INFUSION) 022393 NDA AUTHORIZED GENERIC Pfizer Laboratories Div Pfizer Inc 0069-0983 0069-0983-01 1 KIT in 1 CARTON (0069-0983-01) * 2 mL in 1 VIAL, GLASS (0069-0972-01) * 2 mL in 1 VIAL, GLASS (0069-0961-01)
ISTODAX romidepsin POWDER;IV (INFUSION) 022393 NDA Celgene Corporation 59572-983 59572-983-01 1 KIT in 1 CARTON (59572-983-01) * 2 mL in 1 VIAL, GLASS (59572-961-10) * 2 mL in 1 VIAL, GLASS (59572-972-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength10MG/VIAL
Approval Date:Nov 5, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 16, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Nov 5, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:➤ SubscribePatent Expiration:Aug 22, 2021Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

US Army
McKinsey
McKesson
Cipla
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UBS
Moodys
Fish and Richardson
QuintilesIMS

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