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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
US Army
Baxter
Boehringer Ingelheim
Accenture
Queensland Health
Cerilliant
Chubb

Generated: June 25, 2018

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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 two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
Drug patent expirations by year for ISTODAX
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
Chromadax (TN)
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
Cyclo[(2Z)-2-amino-2-butenoyl-L-valyl-(3S,4E)-3-hydroxy-7-mercapto-4-heptenoyl-D-valyl-D-cysteinyl] Cyclic (35)-Disulfide
D06637
D0L7LC
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
MFCD18433404
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 (USAN)
Romidepsin, >=98% (HPLC)
romidepsina
romidepsine
romidepsinum
s3020
SCHEMBL677497
SR-01000941579
SR-01000941579-1
UNII-CX3T89XQBK
W-5757
ZINC3935130

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;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 022393-001 Nov 5, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for ISTODAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene ISTODAX romidepsin POWDER;IV (INFUSION) 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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Paragraph IV (Patent) Challenges for ISTODAX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 10 mg/vial ➤ Subscribe 2013-11-05

Non-Orange Book US Patents for ISTODAX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,371,361 Method of producing FR901228 ➤ Sign Up
7,396,665 Method of producing FR901228 ➤ Sign Up
8,445,634 Method of producing FR901228 ➤ Sign Up
8,426,556 Method of producing FR901228 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
Cipla
Mallinckrodt
Medtronic
Julphar
Accenture
Johnson and Johnson
McKinsey

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