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Generated: November 20, 2018

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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 three 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. Three 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
Generic Entry Opportunity Date for 022393
Generic Entry Date for 022393*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 022393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISTODAX romidepsin POWDER;INTRAVENOUS 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;INTRAVENOUS 022393 NDA AUTHORIZED GENERIC Teva Parenteral Medicines, Inc. 0703-3125 0703-3125-08 1 KIT in 1 CARTON (0703-3125-08) * 2 mL in 1 VIAL, GLASS * 2 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength10MG/VIAL
Approval Date:Nov 5, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 16, 2018
Regulatory Exclusivity Use:TREATMENT OF PERIPHERAL T-CELL LYMPHOMA (PTCL) IN PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Patent:➤ Sign UpPatent Expiration:Aug 22, 2021Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Aug 22, 2021Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 022393

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 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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