US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| TIKOSYN | 0.125MG; 0.25MG; 0.5MG | capsule · oral | PFIZER | Prescription | 1 Oct 1999 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | DR REDDYS LABS SA | Prescription | 6 Jun 2016 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | SIGMAPHARM LABS LLC | Prescription | 26 Mar 2018 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | BIONPHARMA | Prescription | 10 Apr 2018 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | SUN PHARM | Prescription | 9 Oct 2018 |
| DOFETILDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | AUROBINDO PHARMA LTD | Prescription | 22 Jan 2019 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | MSN | Prescription | 29 Jan 2020 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | ACCORD HLTHCARE | Prescription | 19 Jun 2020 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | GRANULES | Prescription | 14 Oct 2021 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | ANDAS 5 HOLDING | Prescription | 29 Jul 2026 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | STRIDES PHARMA INTL | Discontinued | 9 Oct 2018 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | PRINSTON INC | Discontinued | 17 Dec 2019 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | INGENUS PHARMS LLC | Discontinued | 27 Dec 2019 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | SOMERSET THERAPS LLC | Discontinued | 14 Apr 2022 |
| DOFETILIDE | 0.125MG; 0.25MG; 0.5MG | capsule · oral | TEVA PHARMS USA | Discontinued | 15 Apr 2022 |
EMA European Union — centrally authorised medicines
Tikosyn Pfizer Limited · Withdrawn · authorised 29 Nov 1999 · ATC C01BD04
Therapeutic indication (EMA)
Tikosyn is a Class III antiarrhythmic agent that is indicated for the following: Conversion of persistent atrial fibrillation or atrial flutter to normal sinus rhythm in patients in whom cardioversion by electrical means is not appropriate and in whom the duration of the arrhythmic episode is less than 6 months (see section 5.1). Maintenance of sinus rhythm (after conversion) in patients with persistent atrial fibrillation or atrial flutter. Because TIKOSYN can cause ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic and in whom other antiarrhythmic therapy is not appropriate. Dofetilide has not been shown to be effective in patients with paroxysmal atrial arrhythmias (including paroxysmal atrial fibrillation).
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | DOFETILIDE 125 MCG CAPSULE | $0.20259 | per EA | 23 Sep 2026 |
| US NADAC | DOFETILIDE 250 MCG CAPSULE | $0.19379 | per EA | 23 Sep 2026 |
| US NADAC | DOFETILIDE 500 MCG CAPSULE | $0.19291 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.