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TEMOZOLOMIDE Drug Profile

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Which patents cover Temozolomide, and what generic alternatives are available?

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

The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Fourteen 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:	12
Bulk Api Vendors:	109
Clinical Trials:	697
Patent Applications:	4,647
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

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 (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-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

BCP0726000154

BDBM50034562

BIDD:GT0204

Bio-0147

BPEGJWRSRHCHSN-UHFFFAOYSA-N

BR-72945

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

D0C8EU

DB00853

DL-190

DR000280

DSSTox_CID_23714

DSSTox_GSID_43714

DSSTox_RID_80068

DTXSID5043714

Essex brand of temozolomide

FT-0630936

GTPL7301

HE397401

HMS2051O12

HMS2090B08

HMS2232N13

HMS3264I14

HMS3269P05

HMS3372K13

HMS3393O12

HMS3654N05

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 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

Schering-Plough brand of temozolomide

Scheringbrand of temozolomide

SMR000466338

STK623541

Temodal

Temodal (TN)

Temodar

Temodar (TN)

Temodar (TN) (Schering)

temomedac

Temozolamide

Temozolodida

Temozolodida [Spanish]

Temozolomid

temozolomida

Temozolomide (JAN/USAN/INN)

Temozolomide [INN:BAN]

Temozolomide [USAN:INN:BAN]

Temozolomide, >=98% (HPLC)

Temozolomide, pharmaceutical secondary standard; traceable to USP

Temozolomide, United States Pharmacopeia (USP) Reference Standard

Temozolomide, VETRANAL(TM), analytical standard

Temozolomidum

Temozolomidum [Latin]

TL8005593

TMZ-Bioshuttle

Tox21_112433

Tox21_112433_1

UNII-YF1K15M17Y

YF1K15M17Y

Z1551429743

ZINC1482184

ZLA0002

zlchem 2

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 Pharma Global	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	201742-006	Feb 12, 2014	AB	RX	No	No
Deva Holding As	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	207658-005	Apr 26, 2017	AB	RX	No	No
Chemi Spa	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	204639-002	Nov 23, 2016	AB	RX	No	No
Lannett Co Inc	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203898-001	Feb 10, 2016	AB	RX	No	No
Mylan Pharms Inc	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	205227-006	Jun 29, 2016		DISCN	No	No
Idt Australia Ltd	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	206413-003	Apr 12, 2016	AB	RX	No	No