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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

ISTODAX Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in five countries.

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.

Drug patent expirations by year for ISTODAX
Drug Prices for ISTODAX

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Generic Entry Opportunity Date for ISTODAX
Generic Entry Date for ISTODAX*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for ISTODAX

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SponsorPhase
University of Michigan Cancer CenterPhase 1/Phase 2
Ryan WilcoxPhase 1/Phase 2
TakedaPhase 1/Phase 2

See all ISTODAX clinical trials

Recent Litigation for ISTODAX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Celgene Corporation v. Teva Pharmaceuticals USA, Inc.2015-12-10
Celgene Corporation v. Teva Pharmaceuticals USA, Inc.2015-07-10
Celgene Corporation v. InnoPharma Inc.2014-09-12

See all ISTODAX litigation

Synonyms for ISTODAX
(1S,4S,7Z,10S,16E,21R)-7-Ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo(8.7.6)tricos-16-ene-3,6,9,19,22-pentone
(1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-bis(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
(1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
(1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
(E)-(1S,10S,21R)-7-[(Z)-Ethylidene]-4,21-diisopropyl-2- oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
(E)-(1S,10S,21R)-7-[(Z)-Ethylidene]-4,21-diisopropyl-2- oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
[S-(E)]-N-(3-Hydroxy-7-mercapto-1-oxo-4-heptenyl)-D-valyl-D-cysteinyl-(Z)-2,3-didehydro-2-aminobutanoyl-L-valine (4-1)-Lactone Cyclic (12)-Disulfide
128517-07-7
2692AH
49300-EP2298768A1
49300-EP2311840A1
AB01273968-01
AC1NS1N3
Antibiotic FR 901228
AOB1853
API0005301
BDBM19151
C24H36N4O6S2
CHEBI:61080
CHEMBL343448
Chromadax
CS-0985
CX3T89XQBK
Cyclo((2Z)-2-amino-2-butenoyl-L-valyl-(3S,4E)-3-hydroxy-7-mercapto-4-heptenoyl-D-valyl-D-cysteinyl), cyclic (3?5)-disulfide"
Cyclo[(2Z)-2-amino-2-butenoyl-L-valyl-(3S,4E)-3-hydroxy-7-mercapto-4-heptenoyl-D-valyl-D-cysteinyl] Cyclic (35)-Disulfide
D06637
Depsipeptide
FK 228
FK-228
FK-901228
FK228
FR 901228
FR-901228
FR901228
GTPL7006
HDInhib_000006
HY-15149
Istodax (TN)
L-Valine, N-((3S,4E)-3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoxyl-, (4-1)-lactone, cyclic (1-2)-disulfide
L-Valine, N-(3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-D-valyl-D-cysteinyl-(Z)-2,3-didehydro-2-aminobutanoyl-, xi-lactone, cyclic (1-2)-disulfide, (S-(E))-
L-Valine,3-didehydro-2- aminobutanoyl-,.xi.-lactone, cyclic (1.fwdarw.2)-disulfide
L-Valine,3-didehydro-2-aminobutanoyl-,.xi.-lactone, cyclic (1.fwdarw.2)-disulfide
LS-161318
MolPort-035-395-708
NSC 630176
NSC-630176
NSC-754143
NSC630176
NSC754143
OXA-12,8,20,23-TETRAZABICYCLO[8.7.6]TRICOSANE, CYCLIC PEPTIDE DERIV.
Probes1_000153
Probes2_000337
Romidepsin
Romidepsin (FK228 ,depsipeptide)
Romidepsin (JAN/USAN/INN)
Romidepsin, >=98% (HPLC)
romidepsina
romidepsine
romidepsinum
s3020
SCHEMBL677497
SR-01000941579
SR-01000941579-1
UNII-CX3T89XQBK
W-5757
ZINC3935130
Paragraph IV (Patent) Challenges for ISTODAX
Tradename Dosage Ingredient NDA Submissiondate
ISTODAX POWDER;INTRAVENOUS romidepsin 022393 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 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Celgene ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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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.