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TEMOZOLOMIDE Drug Profile

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Which patents cover Temozolomide, and when can generic versions of Temozolomide launch?

Temozolomide is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Anda Repository, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan, Sun Pharm, Watson Labs Teva, and Zydus Pharms. and is included in fourteen NDAs.

The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for TEMOZOLOMIDE

US Patents:	0
Applicants:	14
NDAs:	14
Suppliers / Packagers:	13
Bulk Api Vendors:	114
Clinical Trials:	790
Patent Applications:	6,660
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TEMOZOLOMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEMOZOLOMIDE
DailyMed Link:	TEMOZOLOMIDE at DailyMed

See drug prices for TEMOZOLOMIDE

Recent Clinical Trials for TEMOZOLOMIDE

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

Sponsor	Phase
Ningbo Yinzhou People's Hospital	Phase 1/Phase 2
BoYuan RunSheng Pharma (Hangzhou) Co., Ltd.	Phase 1/Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 1/Phase 2

See all TEMOZOLOMIDE clinical trials

Recent Litigation for TEMOZOLOMIDE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CANCER RESEARCH TECHNOLOGY LIMITED v. SUN PHARMA GLOBAL FZE	2010-09-15
Cancer Research Technology Limited v. Barr Laboratories Inc.	2007-07-20

See all TEMOZOLOMIDE litigation

Pharmacology for TEMOZOLOMIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Synonyms for TEMOZOLOMIDE

{Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide,} 3, 4-dihydro-3-methyl-4-oxo-

199366-EP2275425A1

3-methyl-4-oxidanylidene-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

3-Methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic acid amide

3-Methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic acid amide (Temozolomide)

3-Methyl-4-oxo-3,4-dihydro-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxylic acid amide(Temozolomide)

3-Methyl-4-oxo-3,4-dihydroimidazo-[5,1-d][1,2,3,5]tetrazine-8-carboxamide

3-Methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide

3-Methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetraazine-8-carboxamide

3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

3-methyl-4-oxo-3H,4H-imidazo[4,3-d][1,2,3,5]tetrazine-8-carboxamide

3-methyl-4-oxo-8-imidazo[5,1-d][1,2,3,5]tetrazinecarboxamide

3-METHYL-4-OXO-8-IMIDAZOLO[5,1-D][1,2,3,5]TETRAZINECARBOXAMIDE

3-methyl-4-oxo-imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

3-Methyl-8-aminocarbonyl-imidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one

3-methyl-8-carbamoyl-imidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one

3,4-Dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide

3,4-Dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide

3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide

3,4-Dihydro-3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

4-methyl-5-oxo-2,3,4,6,8-pentazabicyclo[4.3.0]nona-2,7,9-triene-9-carboxamide

4CA-1225

622T931

8-Carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one

8-CARBAMOYL-3-METHYLIMIDAZO[5,1-D]-1,2,3,5-TETRAZIN-4(3H)-ONE

85622-93-1

A841386

AB0007590

AB00639915_10

AB00639915_11

AB00639915-06

AB00639915-08

AB00639915-09

AC-758

AC1L1K9B

AJ-26318

AK-72945

AKOS005557098

ALBB-021358

AM20110227

AN-5907

ANW-43023

AOB1657

BC206085

BCP03692

BCP0726000154

BDBM50034562

BIDD:GT0204

BPEGJWRSRHCHSN-UHFFFAOYSA-N

BR-72945

BRD-K32107296-001-04-5

BRN 5547136

C6H6N6O2

CAS-85622-93-1

CCG-100870

CCRG 81045

CCRG-81045

CCRIS 8996

CHEBI:72564

CHEMBL810

CJ-23657

CPD000466338

CS-0943

CT0139

CTK8B3724

D06067

DB00853

DL-190

DSSTox_CID_23714

DSSTox_GSID_43714

DSSTox_RID_80068

DTXSID5043714

FT-0630936

GTPL7301

HMS2051O12

HMS2090B08

HMS2232N13

HMS3264I14

HMS3269P05

HMS3372K13

HMS3393O12

HMS3654N05

HMS3713H16

HY-17364

I06-0149

I14-1943

Imidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

Imidazo[5,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-

KB-80840

KS-00000XGV

KS-1216

LS-80558

M & B 39831

M-2350

M-39831

M&B 39831

M&B-39831

MB 39831

MCULE-9414994158

Methazolastone

MFCD00866492

MLS000759447

MLS001424028

MLS002701861

MolPort-003-850-406

NC00120

NCGC00167429-01

NCGC00167429-02

NCGC00167429-04

NCGC00167429-05

NCI60_003316

NSC 362856

NSC-362856

NSC-759883

NSC362856

NSC759883

Pharmakon1600-01502289

PubChem17413

Q-201786

s1237

SAM001246636

SC-17333

Sch 52365

Sch-52365

SCHEMBL3739

SMR000466338

SR-01000759347

SR-01000759347-4

SR-01000759347-5

STK623541

SW197500-4

Temodal

Temodal (TN)

Temodar

Temodar (TN)

Temodar (TN) (Schering)

Temozolamide

Temozolodida

Temozolodida [Spanish]

Temozolomid

temozolomida

Temozolomide (JAN/USAN/INN)

Temozolomide [INN:BAN]

Temozolomide [USAN:INN:BAN]

Temozolomide, >=98% (HPLC)

Temozolomide, Pharmaceutical Secondary Standard; Certified Reference Material

Temozolomide, United States Pharmacopeia (USP) Reference Standard

Temozolomide, VETRANAL(TM), analytical standard

Temozolomidum

Temozolomidum [Latin]

TL8005593

TMZ; NSC 362856; SCH 52365; CCRG 81045

Tox21_112433

Tox21_112433_1

UNII-YF1K15M17Y

YF1K15M17Y

Z1551429743

ZINC1482184

ZLA0002

zlchem 2

Paragraph IV (Patent) Challenges for TEMOZOLOMIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TEMODAR	CAPSULE;ORAL	temozolomide	021029	2008-03-24
TEMODAR	CAPSULE;ORAL	temozolomide	021029	2007-03-20

US Patents and Regulatory Information for TEMOZOLOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	201742-006	Feb 12, 2014	AB	RX	No	No
Chemi Spa	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	204639-005	Nov 23, 2016	AB	RX	No	No
Barr	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	078879-002	Mar 1, 2010	AB	RX	No	No