Mayne Pharma is offering a generic version of Ortho-Cept (desogestrel and ethinyl estradiol 0.15 mg / 0.03 mg) tablets.
This is the fourth oral contraceptive launched this calendar year, after the company launched generic versions of Loestrin 24 FE, Ortho Cyclen, and Ortho Tri-Cyclen. The four products have a combined market value of approximately $315 million in the 12 months ending January 2021, according to IQVIA.
"We are very pleased to expand our Women's Health portfolio which now covers 80% of Obstetrician/Gynecologist oral contraceptive prescription volumes and includes 24 marketed branded generic contraceptives,” said Mayne Pharma’s CEO Scott Richards. “Mayne Pharma is committed to helping meet the needs of women in the United States by providing cost effective, high-quality and novel contraceptive options. The four new products launched this year were sourced from the strategic partnership with Novast Laboratories."
Richards noted that Mayne Pharma has four women's health pipeline products pending at the FDA, including the novel combined oral contraceptive Nextstellis (E4/DRSP) and a generic version of Nuvaring. Nextstellis, which has a FDA target action date in April contains a new estrogen called estetrol or E4 in combination with a progestin, drospirenone. If approved, E4 will be the first new estrogen introduced in the United States for contraceptive use in approximately 50 years, Richards said.