Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day.
Bayer’s Climara Pro Transdermal System 0.045 mg/0.015 mg per day is the reference listed drug for the product. Estradiol and Levonorgestrel Transdermal System, which is primarily used to treat moderate to severe symptoms of menopause, had annual sales of around $45.7 million in the U.S., Zydus said citing IQVIA MAT Aug-2026 numbers.
The ANDA has been designated by the U.S. FDA as a competitive generic therapy. The product is eligible for the 180-day exclusivity period available to certain first approved applicants under the CGT pathway, subject to the provisions of the U.S. Federal Food, Drug, and Cosmetic Act.
The product, also used in postmenopausal women for prevention of osteoporosis, will be manufactured at the group’s manufacturing plant near Ahmedabad, the company said.
Published – October 21, 2026 05:58 pm IST
