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Last Updated: September 25, 2022

ISTODAX Drug Patent 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.

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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Istodax

A generic version of ISTODAX was approved as romidepsin by FRESENIUS KABI USA on October 12th, 2021.

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Drug patent expirations by year for ISTODAX
Drug Prices for ISTODAX

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Recent Clinical Trials for ISTODAX

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

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Paragraph IV (Patent) Challenges for ISTODAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ISTODAX Injection romidepsin 10 mg/vial 022393 1 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 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ISTODAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 See Plans and Pricing See Plans and Pricing
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 See Plans and Pricing See Plans and Pricing
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ISTODAX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Celgene Europe Ltd. Istodax romidepsin EMEA/H/C/002122
treatment of peripheral T-cell lymphoma (PTCL),
Refused no no yes 2013-02-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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