Regulatory Approval Details
Zydus Lifesciences Limited 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. This product is the generic equivalent of Climara Pro® Transdermal System 0.045 mg/0.015 mg per day.
Competitive Generic Therapy Designation
The ANDA has been designated by the USFDA as a Competitive Generic Therapy (CGT). The product is eligible for a 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. Any applicable exclusivity period would commence upon first commercial marketing of the product.
Product Information and Usage
Estradiol and Levonorgestrel Transdermal System is primarily used to treat moderate to severe symptoms of menopause. It is also used in postmenopausal women for prevention of osteoporosis.
Manufacturing and Production
The product will be manufactured at the group's manufacturing plant at Moraiya, near Ahmedabad, Gujarat.
Market Data and Sales
Estradiol and Levonorgestrel Transdermal System had annual sales of approximately USD 45.7 million in the United States according to IQVIA MAT data for August 2026.
Company Regulatory Milestones
The Group now has 458 USFDA approvals and has filed 516 ANDAs with the USFDA as of September 30, 2026.