For atrial fibrillation/atrial flutter of greater than one week duration. Sold as Tikosyn. Every FDA application for this active ingredient: 1 branded and 14 generic.
As of Nov 13, 2026, FDA lists 15 applications for Dofetilide (sold as Tikosyn), first approved Oct 1, 1999, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Dofetilide | Part D | $59.8M | -11% | 81,146 |
| Tikosyn | Part D | $514K | -23% | 102 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm ControlAtrial Fibrillation, Stroke · Kansas City Heart Rhythm Research Foundation | — | Not yet recruiting | Jan 20, 2025 |
| Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial FibrillationPersistent Atrial Fibrillation · Boston Scientific Corporation | Not applicable | Active, not recruiting | Oct 23, 2023 |
| The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) PatientsArrythmia, Cardiomyopathies · University of Rochester | Phase 4 | Recruiting | Sep 5, 2021 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 1, 1999 | TikosynNDA 20931 · New molecular entity | Pfizer | 9 | Marketed |
| Jun 6, 2016 | DofetilideANDA 207058 | Dr Reddys Labs SA | 1 | Marketed |
| Mar 26, 2018 | DofetilideANDA 207746 | Sigmapharm Labs LLC | 0 | Marketed |
| Apr 10, 2018 | DofetilideANDA 208625 | Bionpharma | 1 | Marketed |
| Oct 9, 2018 | DofetilideANDA 208519 | Strides Pharma Intl | 0 | Discontinued |
| Oct 9, 2018 | DofetilideANDA 210466 | Sun Pharm | 1 | Marketed |
| Jan 22, 2019 | DofetildeANDA 210740 | Aurobindo Pharma Ltd | 1 | Marketed |
| Dec 17, 2019 | DofetilideANDA 211223 | Prinston | 0 | Discontinued |
| Dec 27, 2019 | DofetilideANDA 212410 | Ingenus Pharms LLC | 0 | Discontinued |
| Jan 29, 2020 | DofetilideANDA 213220 | Msn | 0 | Marketed |
| Jun 19, 2020 | DofetilideANDA 213338 | Accord Hlthcare | 0 | Marketed |
| Oct 14, 2021 | DofetilideANDA 212750 | Granules | 1 | Marketed |
| Apr 14, 2022 | DofetilideANDA 215323 | Somerset Theraps LLC | 0 | Discontinued |
| Apr 15, 2022 | DofetilideANDA 210018 | Teva Pharms USA | 0 | Discontinued |
| Jul 29, 2026 | DofetilideANDA 212496 | Andas 5 Holding | 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
Pfizer