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Generated: April 20, 2018

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Romidepsin - Generic Drug Details

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What are the generic drug sources for romidepsin and what is the scope of romidepsin freedom to operate?

Romidepsin
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. 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 two drug master file entries for romidepsin. Two suppliers are listed for this compound.
Summary for romidepsin
Synonyms for romidepsin
(1s,4s,7z,10s,16e,21r)-7-ethylidene -4,21-bis(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetra azabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
(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
(1S,4S,7Z,10S,16Z,21R)-7-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-pentaone
(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
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
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
AB01273968-01
AC1L1FWN
AC1NS1N3
ACMC-20msvq
Antibiotic FR 901228
AOB1853
API0005301
AS-16687
BDBM19151
C24H36N4O6S2
CAS-128517-07-7
CHEBI:61080
CHEMBL1998981
CHEMBL2130995
CHEMBL343448
Chromadax
Chromadax (TN)
CS-0985
CTK6B1927
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 (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
DB06176
Depsipeptide
DSSTox_CID_28505
DSSTox_GSID_48579
DSSTox_RID_82777
DTXSID8048579
FK 228
FK-228
FK-901228
FK228
FR 901228
FR-901228
FR901228
GTPL7006
HDInhib_000006
HE071412
HMS3656D16
HY-15149
Istodax
Istodax (TN)
KB-80417
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-035-395-453
MolPort-035-395-708
MolPort-046-033-668
NCGC00229513-01
NCI60_009796
Neuro_000275
NSC 630176
NSC-630176
NSC-754143
NSC630176
NSC754143
OXA-12,8,20,23-TETRAZABICYCLO[8.7.6]TRICOSANE, CYCLIC PEPTIDE DERIV.
PL044063
Probes1_000153
Probes2_000337
Romidepsin (FK228 ,depsipeptide)
Romidepsin (FK228, depsipeptide)
Romidepsin (JAN/USAN/INN)
Romidepsin (USAN)
Romidepsin [USAN:INN]
Romidepsin, >=98% (HPLC)
romidepsina
romidepsine
romidepsinum
s3020
SCHEMBL10292909
SCHEMBL677497
SCHEMBL869004
SCHEMBL928586
SR-01000941579
SR-01000941579-1
Tox21_112907
UNII-CX3T89XQBK
W-201011
W-5757
ZINC100052983
ZINC3935130

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

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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Non-Orange Book US Patents for romidepsin

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
8,445,634 Method of producing FR901228 ➤ Sign Up
9,371,361 Method of producing FR901228 ➤ Sign Up
7,396,665 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:

UBS
Baxter
Fish and Richardson
Harvard Business School
Julphar
US Army
Mallinckrodt
Covington
Argus Health

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