Posted from: Wednesday, June 29, 2016 - 11:46 AM - Present

Generic to Tikosyn Capsules Launched

June 7, 2016 - The U.S. Food and Drug Administration (FDA) approved dofetilide, a generic alternative to Pfizer’s Tikosyn® (dofetilide), which is available in 125mcg, 250mcg and 500mcg capsules.  Dofetilide is manufactured by Mayne Pharma, which was granted 180 days of generic exclusivity.  Tikosyn is an anti-arrhythmic agent used to prevent irregular heartbeats, including atrial fibrillation and atrial flutter. According to IMS health, annual U.S. sales of Tikosyn are approximately $200 million.   

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Tuesday, October 15, 2019 - 11:28 PM.