Sold as Tasigna. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Nilotinib Hydrochloride (sold as Tasigna), first approved Oct 29, 2007, with 10 new uses approved and 0 published complete response letters.
| Tasigna | Part D | $411M | -4% | 3,250 |
| Nilotinib HCl | Part D | $96.7M | New | 1,829 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening TrialAdvanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8 · National Cancer Institute (NCI) | Phase 2 | Recruiting | Oct 3, 2022 |
| Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment TrialMetastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Sep 26, 2022 |
| Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid LeukemiaChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · SWOG Cancer Research Network | Phase 2 | Active, not recruiting | Aug 31, 2018 |
| The Drug Rediscovery Protocol (DRUP Trial)Cancer, Tumors · The Netherlands Cancer Institute | Phase 2 | Recruiting | Oct 5, 2016 |
| Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or NilotinibChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia · M.D. Anderson Cancer Center | Phase 2 | Recruiting | Dec 11, 2012 |
| Oct 29, 2007 | TasignaNDA 22068 · New molecular entity | Novartis | 33 | Marketed |
| Jan 5, 2024 | Nilotinib HydrochlorideANDA 203640 | Apotex | 0 | Marketed |
| Nov 19, 2025 | Nilotinib Hydrochloride, Nilotinib Hydrochloride DihydrateANDA 209651 | Hetero Labs Ltd V | 0 | Marketed |
| Nov 19, 2025 | Nilotinib HydrochlorideANDA 218350 | Dr Reddys | 0 | Marketed |
| Nov 19, 2025 | Nilotinib HydrochlorideANDA 218544 | Msn | 0 | Marketed |
| Dec 15, 2025 | Nilotinib Hydrochloride, NilotinibANDA 218532 | Torrent | 0 | Marketed |
| Jun 26, 2026 | Nilotinib HydrochlorideANDA 219134 | Teva Pharms Inc | 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
Novartis
Apotex