Mayne Pharma Inc. has received approval from the US Food and Drug Administration (FDA) to market dofetilide capsules, a generic alternative to Tikosyn, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.
Mayne Pharma was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for dofetilide capsules. As a result, the FDA awarded Mayne Pharma 180 days of market exclusivity for its generic alternatives. The company immediately began selling the product in 125 mcg (0.125 mg), 250 mcg (0.25 mg) and 500 mcg (0.5 mg) doses.
The timing of Mayne Pharma’s market approval coincided with the FDA withdrawing the Tikosyn Risk Evaluation and Mitigation Strategies (REMS) programme, which limited the drug’s availability and dispensation to certified prescribers, pharmacies and wholesalers. The removal of the drug’s REMS program means Mayne Pharma’s dofetilide capsules can be broadly available at pharmacies nationwide — improving accessibility for current and new patients.
“Mayne Pharma has a long history of developing high-quality generic products that offer patients affordable options and improved access to medications that enhance their lives,” said Stefan Cross, president of Mayne Pharma USA. “The launch of Mayne Pharma’s dofetilide capsules with 180 days of market exclusivity represents a large step forward in our company’s growth — underscoring our commitment through our staff and investments to bring complex generic alternatives to the marketplace.”
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 United States were approximately $200 million for the twelve months ended April 2016. Mayne Pharma has an agreement with its long-time partner, Johnson Matthey Inc., which supplies the active pharmaceutical ingredient (API), to share equally the profits from the sale of this product. Tikosyn is a registered trademark of Pfizer Inc.
Currently, Mayne Pharma has more than 35 generic and branded drug products in development for the market within the United States, including 12 drug applications pending at the FDA.