7 June 2016 - First generic approval to Pfizer’s US$200m Tikosyn brand.

Mayne Pharma Group Limited  is pleased to announce that the US FDA has granted approval of its Abbreviated New Drug Application (ANDA) for dofetilide 125 mcg, 250 mcg and 500 mcg capsules in the United States.

Mayne Pharma was the first company to file a substantially complete ANDA containing a Paragraph IV certification for dofetilide capsules and as a result has been awarded 180-days of market exclusivity. Mayne Pharma has immediately commenced commercial launch.

Dofetilide capsules are a generic version of Pfizer’s Tikosyn capsules, an anti-arrhythmic agent used to prevent irregular heartbeats such as atrial fibrillation and atrial flutter. According to IMS Health, annual sales of Tikosyn in the US were approximately US$200 million for the twelve months ended April 2016.

For more details, go to: https://www.maynepharma.com/media/1630/myx-receives-first-generic-approval-of-tikosyn-capsules.pdf