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Generated: September 25, 2018

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TEMODAR Drug Profile

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

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.

The generic ingredient in TEMODAR 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.

Drug patent expirations by year for TEMODAR
Pharmacology for TEMODAR
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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 (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 (TN)
Temodar (TN) (Schering)
temomedac
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; 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 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 TEMODAR

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

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Paragraph IV (Patent) Challenges for TEMODAR
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 140 mg and 180 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Healthtrust
Accenture
AstraZeneca
Medtronic
Colorcon
QuintilesIMS
McKesson
Deloitte

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