Amneal wins FDA approval for generic Ortho Evra, with 180 days of exclusivity pathway
1 March 2021 -

Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Friday the receipt of US Food and Drug Administration (FDA) Abbreviated New Drug Application (ANDA) approval for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System.

The company said it expects to begin commercialization activities with immediate effect.

Amneal added that the 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.

According to the company, 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. It may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg).

In connection with its approval of generic Ortho Evra, the company received a Competitive Generic Therapy (CGT) designation from the US FDA, with 180 days of exclusivity.

Additionally, Zafemy will provide patients with another option to the one equivalent product, Xulane, manufactured by Mylan. According to IQVIA, the US annual sales for Xulane for the 12 months ended December 2020 were approximately USD332m.