Zydus Lifesciences Limited has secured final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the Estradiol and Levonorgestrel Transdermal System. This once-weekly hormone therapy patch delivers a daily dosage of 0.045 mg of estradiol and 0.015 mg of levonorgestrel

The U.S. FDA designated this Abbreviated New Drug Application (ANDA) as a Competitive Generic Therapy (CGT). The first-approved applicant can receive a 180-day market exclusivity period under federal law, which officially starts once the company launches and commercially markets the product.

Estradiol and Levonorgestrel Transdermal System  is primarily used treat moderate to severe symptoms of menopause. It is also used in postmenopausal women for prevention of osteoporosis. The product will be manufactured at the group’s manufacturing plant at Moraiya, near Ahmedabad, Gujarat.

Estradiol and Levonorgestrel Transdermal System had annual sales of approximately USD 45.7 mn in the United States. (IQVIA MAT Aug-2026). The Group now has 458 approvals and has so far filed 516 ANDA with the USFDA.