Xiromed debuts generic Taytulla

A new generic oral contraceptive is now available.

The Food and Drug Administration has given its blessing to Xiromed for Gemmily (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), in a dosage strength of 1 mg/20 mcg. It is an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy

The medication is the generic of AbbVie's Taytulla. It is the first generic to Taytulla approved in the United States. Commercialization activities for Gemmily will begin immediately.

Xiromed CEO Narasimhan Mani said, “The launch of this first-to-market generic is an important milestone for Xiromed, demonstrating the strength of our development pipeline, and further establishing our position as a leading generic pharmaceutical company in the women’s health segment. The Xiromed team is excited to offer this first generic product, furthering our commitment to providing high quality generics to patients in the United States.”

Taytulla had a market value of $157 million for the 12 months ending August 2020, according to IQVIA.