Zydus gets USFDA approval for estradiol and levonorgestrel transdermal system
The product has been designated as a Competitive Generic Therapy and is eligible for a 180-day exclusivity period, subject to applicable provisions
Zydus Lifesciences has announced that the United States Food and Drug Administration (USFDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day (URLD: Climara Pro Transdermal System 0.045 mg/0.015 mg per day).
The USFDA has designated the ANDA as a Competitive Generic Therapy (CGT). 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 US Federal Food, Drug, and Cosmetic Act. Any exclusivity period, where applicable, would commence upon the first commercial marketing of the product.
Estradiol and Levonorgestrel Transdermal System is primarily used to treat moderate to severe symptoms of menopause. It is also used in postmenopausal women for the prevention of osteoporosis. The product will be manufactured at the group’s manufacturing plant in Moraiya, near Ahmedabad, Gujarat.
According to IQVIA MAT August 2026 data, Estradiol and Levonorgestrel Transdermal System had annual sales of approximately USD 45.7 million in the United States.
As of 30 September 2026, the group has 458 approvals and has filed 516 ANDAs with the USFDA.