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Generated: December 10, 2018

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THALIDOMIDE - Generic Drug Details

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

Thalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Thalidomide has forty-seven patent family members in nineteen countries.

There are eleven drug master file entries for thalidomide. One supplier is listed for this compound.

Pharmacology for THALIDOMIDE
Medical Subject Heading (MeSH) Categories for THALIDOMIDE
Synonyms for THALIDOMIDE
.alpha.-(N-Phthalimido)glutarimide
.alpha.-N-Phthalylglutaramide
.alpha.-Phthalimidoglutarimide
( inverted question mark)-2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione
( inverted question mark)-Thalidomide
(?)-Thalidomide
(.+/-.)-Thalidomide
(+-)-N-(2,6-Dioxo-3-piperidyl)phthalimide
(+-)-Thalidomide
(+/-)-2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione
(+/-)-N-(2,6-Dioxo-3-piperidinyl)phthalimide
(+/-)-N-(2,6-dioxo-3-piperidyl)phthalimide
(+/-)-THALIDOMIDE
(+/-)-Thalidomide, >=98%, powder
(A+/-)-Thalidomide
(inverted question mark)-Thalidomide
(y)-Thalidomide
[(R,S)-2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione
1,3-Dioxo-2-(2,6-dioxopiperidin-3-yl)isoindoline
1012310-87-0
14088-68-7
153T873
1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)-
1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)-, (R)-
1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)-, (S)-
1H-Isoindole-1,3(2H)-dione, 2-(2,6-dioxo-3-piperidinyl)-
1H-Isoindole-1,3(2H)-dione, 2-(2,6-dioxo-3-piperidinyl)-, (+-)-
2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione
2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione #
2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione
2-(2,6-Dioxo-piperidin-3-yl)-isoindole-1,3-dione
2-(2,6-dioxoazaperhydroin-3-yl)benzo[c]azoline-1,3-dione
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione
2-(2,6-dioxopiperidin-3-yl)-2,3-dihydro-1H-isoindole-1,3-dione
2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione
2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione
2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1H-isoindole-1,3-dione
2,6-Dioxo-3-phthalimidopiperidine
3-Phthalimidoglutarimide
50-35-1
731-40-8
AB00052362
AB00052362_14
AB00052362_15
AB00052362-11
AB00052362-12
AB00052362-13
AB0011813
AB2000009
AC-917
AC1L1KBZ
AC1Q6FJA
AI3-50606
AK-91024
AKOS009529198
Algosediv
alpha-(N-Phthalimido)glutarimide
alpha-N-Phthalylglutaramide
alpha-Phthalimidoglutarimide
AN-15419
ANW-53225
ARONIS24496
AS-12367
Asidon 3
Asmadion
Asmaval
BBL023439
BC204656
BDBM50070114
Bio1_000387
Bio1_000876
Bio1_001365
Bio2_000418
Bio2_000898
Bonbrain
Bonbrrin
BPBio1_000159
BRD-A93255169-001-06-9
BRD-A93255169-001-24-2
BRN 0030233
BSPBio_000143
BSPBio_001156
BSPBio_003330
C07910
C13H10N2O4
Calmore
Calmorex
CAS-50-35-1
CCG-39878
CCRIS 8148
Celgene
Celgene Brand of Thalidomide
CHEBI:74947
CHEMBL468
cMAP_000022
Contergan
Corronarobetin
CPD000058524
CS-1084
CTK8B6291
D00754
D0U7GK
DB01041
Distaval
Distaxal
Distoval
DivK1c_000051
DSSTox_CID_2524
DSSTox_GSID_22524
DSSTox_RID_76611
DTXSID9022524
E-217
Ectiluran
EINECS 200-031-1
ENMD 0995
Enterosediv
EU-0101224
FT-0600001
FT-0631211
Gastrinide
Glupan
Glutanon
Glutarimide, 2-phthalimido-
Grippex
GTPL7327
HE003853
HE262374
HE302012
HE383992
HE384032
Hippuzon
HMS1362J17
HMS1568H05
HMS1792J17
HMS1922E12
HMS1990J17
HMS2090O05
HMS2093G15
HMS2095H05
HMS2234C07
HMS3259C22
HMS3263F10
HMS3266F13
HMS3373E06
HMS3373G15
HMS3403J17
HMS3654A20
HMS500C13
HSDB 3586
HY-14658
I06-0197
I14-23643
IDI1_000051
IDI1_002173
Imida-lab
Imidan (peyta)
Imidene
IN1061
Isomin
J90042
K 17
K-17
KB-61574
KBio1_000051
KBio2_000496
KBio2_002322
KBio2_003064
KBio2_004890
KBio2_005632
KBio2_007458
KBio3_000911
KBio3_000912
KBio3_002550
KBio3_002802
KBioGR_000496
KBioGR_001474
KBioGR_002322
KBioSS_000496
KBioSS_002324
Kedavon
Kevadon
KS-00000H64
Lopac0_001224
LP01224
LS-109463
LS-140
M-1523
MCULE-6327754946
MFCD00153873
MLS000069353
MolPort-003-665-582
N-(2,6-dioxo-3-piperidinyl)phthalimide
N-(2,6-Dioxo-3-piperidyl)phthalimide
n-(2,6-dioxopiperidin-3-yl)phthalimide
N-Phthalimidoglutamic acid imide
N-Phthaloylglutamimide
N-Phthalyl-glutaminsaeure-imid
N-Phthalyl-glutaminsaeure-imid [German]
N-Phthalylglutamic acid imide
NC00600
NCGC00015989-03
NCGC00015989-04
NCGC00015989-05
NCGC00015989-06
NCGC00015989-07
NCGC00015989-08
NCGC00015989-09
NCGC00015989-10
NCGC00015989-11
NCGC00015989-12
NCGC00015989-13
NCGC00015989-14
NCGC00015989-16
NCGC00015989-17
NCGC00024708-02
NCGC00024708-03
NCGC00024708-04
NCGC00024708-05
NCGC00024708-06
NCGC00024708-07
NCGC00024708-08
NCGC00024708-09
NCGC00024708-10
NCGC00024708-11
NCGC00254343-01
NCGC00261909-01
NCI60_023904
NCIOpen2_003188
Neaufatin
Neosedyn
Neosydyn
Nerosedyn
Neufatin
Neurodyn
Neurosedin
Neurosedym
Neurosedyn
Nevrodyn
Nibrol
NINDS_000051
Noctosediv
Noxodyn
NSC 527179
NSC-527179
NSC-66847
NSC-758479
NSC-91729
NSC-91730
NSC527179
NSC66847
NSC758479
NSC91729
NSC91730
Pangul
Pantosediv
Pharmakon1600-01503607
Pharmion
Phthalimide, N-(2,6-dioxo-3-piperidyl)-
Phthalimide, N-(2,6-dioxo-3-piperidyl)-, (+-)-
Phthalimide,6-dioxo-3-piperidyl)-
Phthalimide,6-dioxo-3-piperidyl)-, (-)-
Phthalimide,6-dioxo-3-piperidyl)-, (+)-
Phthalimide,6-dioxo-3-piperidyl)-, D-(+)-
Phthalimide,6-dioxo-3-piperidyl)-, L-(-)-
Poly-Giron
Polygripan
Predni-Sediv
Prestwick_463
Prestwick0_000192
Prestwick1_000192
Prestwick2_000192
Prestwick3_000192
Pro-Bam M
Pro-ban M
Profarmil
Psycholiquid
Psychotablets
Quetimid
Quietoplex
RP29207
S1193
SAM002564245
Sandormin
SBI-0051191.P003
SC-18573
SCHEMBL15197560
SCHEMBL7581
Sedalis
Sedalis sedi-lab
Sedimide
Sedin
Sedisperil
Sedoval
Shin-naito S
Shinnibrol
Sleepan
Slipro
SMR000058524
Softenil
Softenon
SPBio_000893
SPBio_002064
SPECTRUM1503607
Spectrum2_000707
Spectrum3_001715
Spectrum4_001087
Spectrum5_001791
SR-01000076184
SR-01000076184-1
ST24027458
ST51039042
STL356025
Synovir
Talargan
Talidomida
Talidomida [INN-Spanish]
Talidomide
Talidomide [DCIT]
Talimol
Talinol
Talismol
Talizer
TC-141970
Telagan
Telargan
Telargean
Tensival
Thaled
Thaled (TN)
Thalidomide (+ and -)
Thalidomide (+ and-)
THALIDOMIDE (AIDS INITIATIVE)
Thalidomide (JAN/USP/INN)
Thalidomide (soluble form)
Thalidomide [USAN:INN:BAN]
Thalidomide [USAN:USP:INN:BAN:JAN]
Thalidomide Celgene
Thalidomide Pharmion
Thalidomide, United States Pharmacopeia (USP) Reference Standard
Thalidomidum
Thalidomidum [INN-Latin]
Thalidomine USP26
Thalin
Thalinette
Thalomid
Thalomid (TM)
Thalomid (TN)
Thalomid (TN) (Celgene)
Thalomid, Thalidomide
Thalomide
Theophilcholine
Tox21_110275
Tox21_110275_1
Tox21_300580
Tox21_501224
UEJJHQNACJXSKW-UHFFFAOYSA-N
UPCMLD-DP139
UPCMLD-DP139:001
Valgis
Valgraine
W-105969
WLN: T56 BVNVJ C- DT6VMVTJ
WLN: T56 BVNVJ C- DT6VMVTJ -D
WLN: T56 BVNVJ C- DT6VMVTJ -L
Yodomin
Z1550675451

US Patents and Regulatory Information for THALIDOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-004 Jan 10, 2007 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 RX Yes No ➤ 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 THALIDOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 ➤ Sign Up ➤ Sign Up
Celgene THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for THALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036 France ➤ Sign Up PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
00358 Netherlands ➤ Sign Up PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/GB08/039 United Kingdom ➤ Sign Up PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416
C0036 France ➤ Sign Up PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Argus Health
Queensland Health
Daiichi Sankyo
Accenture
Merck
Cipla
Boehringer Ingelheim
McKesson

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