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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 fifteen patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in THALOMID is thalidomide. There are ten 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

US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	100
Clinical Trials:	71
Patent Applications:	4,768
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

Pharmacology for THALOMID

Physiological Effect

Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for THALOMID

Angiogenesis Inhibitors

Immunosuppressive Agents

Leprostatic Agents

Teratogens

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

(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

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 (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 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	020785-003	Jan 17, 2003		RX	Yes	Yes
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003		RX	Yes	No
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes			Y
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003		RX	Yes	No

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Expired US Patents for THALOMID

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

Paragraph IV (Patent) Challenges for THALOMID

Drugname	Dosage	Strength	RLD	Date
	Capsules	150 mg
	Capsules	50 mg and 100 mg
	Capsules	200 mg

Non-Orange Book US Patents for THALOMID

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
6,767,326	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
9,006,267	Pharmaceutical compositions and dosage forms of thalidomide

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International Patents for THALOMID

Country	Document Number	Estimated Expiration
Taiwan	200731973
Canada	2352629
Japan	5244268
Mexico	PA05005162

Supplementary Protection Certificates for THALOMID

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
00358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/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