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Last Updated: September 27, 2021

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Romidepsin - Generic Drug Details

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What are the generic sources for romidepsin and what is the scope of patent protection?

Romidepsin is the generic ingredient in two branded drugs marketed by Celgene and Teva Pharms Usa Inc, and is included in two NDAs. 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 three drug master file entries for romidepsin. Two suppliers are listed for this compound.

Drug Prices for romidepsin

See drug prices for romidepsin

Recent Clinical Trials for romidepsin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sun Yat-sen UniversityPhase 2
University of VirginiaPhase 2
Food and Drug Administration (FDA)Phase 2

See all romidepsin clinical trials

Paragraph IV (Patent) Challenges for ROMIDEPSIN
Tradename Dosage Ingredient NDA Submissiondate
ISTODAX POWDER;INTRAVENOUS romidepsin 022393 2013-11-05

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;INTRAVENOUS 022393-001 Nov 5, 2009 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharms Usa Inc ROMIDEPSIN romidepsin SOLUTION;INTRAVENOUS 208574-002 Mar 13, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Usa Inc ROMIDEPSIN romidepsin SOLUTION;INTRAVENOUS 208574-001 Mar 13, 2020 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 romidepsin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Try it Free ⤷  Try it Free
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Try it Free ⤷  Try it Free
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Moodys
AstraZeneca
Medtronic
Express Scripts
Baxter

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