Amneal cleared to launch Zafemy, its Ortho Evra generic

Amneal has received FDA approval for its generic of Ortho Evra (150 mcg/day Norelgestromin and 35 mcg/day ethinyl estradiol transdermal system), a contraceptive patch that it will market under the proprietary name Zafemy.

The company also was granted a competitive generic therapy designation for the product, giving it 180 days of market exclusivity. Amnealexpects to begin commercialization activities on March 1, 2021. Though Ortho Evra was discontinued by the manufacturer, Mylan's Xulane has thus far been the only equivalent available until now.

“Today’s approval is a significant milestone for patients and our company,” Amneal co-CEOs Chirag and Chintu Patel said in a statement. “Zafemy will provide patients with another option to the one equivalent product — Xulane, manufactured by Mylan — currently on the market. It also demonstrates the continued successful execution of our strategy to develop and commercialize complex generics and represents the 10th of 15 high-value complex products we expect to launch before August 2021.”

Zafemy is a patch indicated for the prevention of pregnancy in women with a body mass index of less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Zafemy may be less effective in preventing pregnancy in women at or above 198 lbs.

The product had a market value of roughly $332 million for the 12 months ended December 2020, according to IQVIA.