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Generated: September 18, 2019

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Temozolomide - Generic Drug Details

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

Temozolomide is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in sixteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Temozolomide has thirty-six patent family members in twenty-three countries.

There are sixteen drug master file entries for temozolomide. Sixteen suppliers are listed for this compound.

Pharmacology for temozolomide
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating 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

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
Apotex Inc TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204159-004 Jul 5, 2018 DISCN No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 AB RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
Amerigen Pharms Ltd TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203490-005 Jul 13, 2016 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Zydus Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206750-005 Jul 31, 2017 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Chemi Spa TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204639-006 Nov 23, 2016 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528-001 Feb 27, 2017 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
>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 temozolomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999   Try a Free Trial   Try a Free Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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