Sold as Temodar. Every FDA application for this active ingredient: 2 branded and 16 generic.
As of Nov 15, 2026, FDA lists 18 applications for Temozolomide (sold as Temodar), first approved Aug 11, 1999, with 8 new uses approved and 0 published complete response letters.
| Temodar (J8700) | Part B | $2.6M | +48% | 5,108 |
| Temodar (J9328) | Part B | $444K | +3% | 12 |
| Temodar | Part D | $221K | New | 0 |
| Temozolomide | Part D | $40K | +4% | 11 |
| Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 TrialGlioblastoma, IDH-Wildtype · Mayo Clinic | Phase 3 | Not yet recruiting | Nov 13, 2026 |
| Naxitamab Enabled Transplant-Free Study in High-Risk NeuroblastomaNeuroblastoma · Giselle Sholler | Phase 2 | Recruiting | Nov 12, 2026 |
| Novel endOvascular Therapy With beVAcizumab and Cannabinoids for GlioblastomaGBM · Unity Health Toronto | Phase 1 | Not yet recruiting | Nov 2, 2026 |
| TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETSGastroenteropancreatic Neuroendocrine Tumors · Tata Memorial Hospital | Phase 3 | Not yet recruiting | Nov 2, 2026 |
| A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region UnmethylatedNewly Diagnosed Glioblastoma, MGMT-Unmethylated Glioblastoma · Sun Yat-sen University | Not applicable | Not yet recruiting | Oct 26, 2026 |
| IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade AstrocytomasAstrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4 · German Cancer Research Center | Phase 2 | Not yet recruiting | Oct 22, 2026 |
| Tris-CAR-T Cell Therapy Targeting CD44 and CD133 in Newly Diagnosed GlioblastomaNewly Diagnosed Glioblastoma, IDH-wildtype · Beijing Tiantan Hospital | Phase 2 / Phase 3 | Not yet recruiting | Oct 14, 2026 |
| IMPT Versus IMRT for Diffuse Intrinsic Pontine GliomaDiffuse Intrinsic Pontine Gliomas (DIPG) · Shandong Cancer Hospital and Institute | Phase 3 | Not yet recruiting | Oct 9, 2026 |
| Aug 11, 1999 | TemodarNDA 21029 · New molecular entity | Merck Sharp Dohme | 30 | Discontinued |
| Feb 27, 2009 | TemodarNDA 22277 · New dosage form | Merck Sharp Dohme | 14 | Marketed |
| Mar 1, 2010 | TemozolomideANDA 78879 | Heritage | 8 | Discontinued |
| Feb 12, 2014 | TemozolomideANDA 201742 | Sun Pharm | 9 | Marketed |
| May 8, 2015 | TemozolomideANDA 203691 | Amneal Pharms | 4 | Marketed |
| Feb 10, 2016 | TemozolomideANDA 203898 | Eirgen | 3 | Marketed |
| Apr 12, 2016 | TemozolomideANDA 206413 | Chartwell | 1 | Marketed |
| Apr 27, 2016 | TemozolomideANDA 206309 | Rising | 3 | Marketed |
| Jun 29, 2016 | TemozolomideANDA 205227 | Pharmazone | 0 | Discontinued |
| Jul 13, 2016 | TemozolomideANDA 203490 | Ani Pharms | 4 | Discontinued |
| Nov 23, 2016 | TemozolomideANDA 204639 | Chemi Spa | 3 | Marketed |
| Feb 27, 2017 | TemozolomideANDA 201528 | Accord Hlthcare | 4 | Marketed |
| Apr 18, 2017 | TemozolomideANDA 203959 | Watson Labs Teva | 0 | Discontinued |
| Apr 26, 2017 | TemozolomideANDA 207658 | Deva Holding As | 1 | Marketed |
| Jul 31, 2017 | TemozolomideANDA 206750 | Zydus Pharms | 2 | Marketed |
| Jul 5, 2018 | TemozolomideANDA 204159 | Apotex | 3 | Discontinued |
| Nov 23, 2021 | TemozolomideANDA 213328 | Nivagen | 0 | Discontinued |
| Aug 23, 2024 | TemozolomideANDA 210030 | Hetero Labs Ltd V | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Accord Hlthcare
Zydus Pharms
Apotex