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THALOMID Drug Profile

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When do Thalomid patents expire, and when can generic versions of Thalomid launch?

Thalomid is a drug marketed by Celgene and is included in one NDA. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has forty-seven patent family members in nineteen countries.

The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.

Summary for THALOMID

International Patents:	47
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	107
Clinical Trials:	71
Patent Applications:	4,807
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for THALOMID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THALOMID
DailyMed Link:	THALOMID at DailyMed

See drug prices for THALOMID

Generic Entry Opportunity Date for THALOMID

NDA:

020785

Dosage:

CAPSULE;ORAL

^*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 THALOMID

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

Sponsor	Phase
Nanfang Hospital of Southern Medical University	Phase 3
Janssen, LP	Phase 2
University of Miami	N/A

See all THALOMID clinical trials

Recent Litigation for THALOMID

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.	2019-07-12
CELGENE CORPORATION v. APOTEX INC.	2019-06-19
CELGENE CORPORATION v. AUROBINDO PHARMA LIMITED	2019-02-14

See all THALOMID litigation

PTAB Litigation

Petitioner	Date
Coalition For Affordable Drugs VI LLC	2015-04-23

See all THALOMID litigation

Pharmacology for THALOMID

Physiological Effect

Decreased Immunologically Active Molecule Activity

Synonyms for THALOMID

.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

(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

BCP19772

BDBM50070114

Bio1_000387

Bio1_000876

Bio1_001365

Bio2_000418

Bio2_000898

Bonbrain

Bonbrrin

BPBio1_000159

BRD-A93255169-001-04-4

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

CHEBI:74947

CHEMBL468

cMAP_000022

Contergan

Corronarobetin

CPD000058524

CS-1084

CTK8B6291

D00754

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

Hippuzon

HMS1362J17

HMS1568H05

HMS1792J17

HMS1922E12

HMS1990J17

HMS2090O05

HMS2093G15

HMS2095H05

HMS2234C07

HMS3259C22

HMS3263F10

HMS3266F13

HMS3373E06

HMS3373G15

HMS3403J17

HMS3654A20

HMS3712H05

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

SR-01000076184-3

SR-01000076184-5

SR-01000076184-8

ST24027458

ST51039042

STL356025

SW196678-4

Synovir

Talargan

Talidomida

Talidomida [INN-Spanish]

Talidomide

Talidomide [DCIT]

Talimol

Talinol

Talismol

Talizer

TC-141970

Telagan

Telargan

Telargean

Tensival

Thaled

Thaled (TN)

thalidomide

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

Thalidomide,(S)

Thalidomidum

Thalidomidum [INN-Latin]

Thalidomine USP26

Thalin

Thalinette

Thalomid (TM)

Thalomid (TN)

Thalomid (TN) (Celgene)

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

Paragraph IV (Patent) Challenges for THALOMID

Tradename	Dosage	Ingredient	NDA	Submissiondate
THALOMID	CAPSULE;ORAL	thalidomide	020785	2014-02-03
THALOMID	CAPSULE;ORAL	thalidomide	020785	2006-12-18

US Patents and Regulatory Information for THALOMID

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	020785-004	Jan 10, 2007		RX	Yes	No
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes			Y
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes

Expired US Patents for THALOMID

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

International Patents for THALOMID

Country	Patent Number	Estimated Expiration
Japan	5269280
European Patent Office	2277512
South Korea	100671366
Australia	2003290982

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	SPC/GB08/039	United Kingdom		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
0688211	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0620232	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416