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TEMOZOLOMIDE Drug Profile
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See Plans and PricingWhich patents cover Temozolomide, and when can generic versions of Temozolomide launch?
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, Rising, 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. Fourteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
US ANDA Litigation and Generic Entry Outlook for Temozolomide
A generic version of TEMOZOLOMIDE was approved as temozolomide by BARR on March 1st, 2010.
Summary 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 |
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 |
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 | Start Trial | Start Trial | Start Trial | |||
| Deva Holding As | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 207658-005 | Apr 26, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Chemi Spa | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204639-002 | Nov 23, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lannett Co Inc | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898-001 | Feb 10, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 205227-006 | Jun 29, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Idt Australia Ltd | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 206413-003 | Apr 12, 2016 | AB | RX | No | No | 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 |
