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Last Updated: January 28, 2020

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TEMODAR Drug Profile

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When do Temodar patents expire, and what generic alternatives are available?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

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

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

US ANDA Litigation and Generic Entry Outlook for Temodar

A generic version of TEMODAR was approved as temozolomide by BARR on January 28th, 2020.

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Drug patent expirations by year for TEMODAR
Drug Prices for TEMODAR

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Recent Clinical Trials for TEMODAR

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
National Cancer Institute (NCI)Phase 2/Phase 3
M.D. Anderson Cancer CenterEarly Phase 1

See all TEMODAR clinical trials

Recent Litigation for TEMODAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
CANCER RESEARCH TECHNOLOGY LIMITED v. SUN PHARMA GLOBAL FZE2010-09-15
Cancer Research Technology Limited v. Barr Laboratories Inc.2007-07-20

See all TEMODAR litigation

Synonyms for TEMODAR
{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 (TN)
Temodar (TN) (Schering)
Temozolamide
Temozolodida
Temozolodida [Spanish]
Temozolomid
temozolomida
temozolomide
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 TEMODAR
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 TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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