Amneal gets USFDA approval for Norelgestromin and Ethinyl Estradiol Transdermal System

The company granted 180 days of exclusivity under FDA Competitive Generic Therapy (CGT) approval pathway

Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System. In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity.

Amneal’s Norelgestromin and Ethinyl Estradiol Transdermal System is the generic version of the reference listed drug (RLD) Ortho Evra and will be marketed under the proprietary name Zafemy. Zafemy is a 12.5 cm2 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 (90 kg). The Company expects to begin commercialisation activities on March 1, 2021.

“Today’s approval is a significant milestone for patients and our company,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “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 commercialise complex generics and represents the 10th of 15 high-value complex products we expect to launch before August 2021.”

According to IQVIA, a leading healthcare data and analytics provider, US annual sales for Xulane for the 12 months ended December 2020 were approximately $332 million.

Amneal PharmaceuticalsANDA approvalEthinyl Estradiol Transdermal SystemNorelgestrominOrtho Evratransdermal productZafemy
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