Zydus Lifesciences Ltd on Wednesday said it has received the final approval from the US health regulator to market a generic transdermal system for treatment of moderate to severe symptoms of menopause and prevent postmenopausal osteoporosis.
The final approval granted by the US Food and Drug Administration (USFDA) is for Estradiol and Levonorgestrel Transdermal System (0.045 mg/0.015 mg per day), the company said in a regulatory filing.
The product has been designated as a Competitive Generic Therapy (CGT) and is eligible for 180 days of CGT exclusivity, which will commence upon its first commercial marketing, it added.
The approved patch is the generic equivalent of the reference listed drug Climara Pro Transdermal System. It will be manufactured at the group’s formulation facility at Moraiya, near Ahmedabad.
Citing IQVIA MAT August 2026 data, Zydus said the Estradiol and Levonorgestrel Transdermal System had annual sales of about USD 45.7 million in the US market.
With this approval, the group now has 458 approvals and has so far filed 516 Abbreviated New Drug Applications with the USFDA, the filing added.
Published on October 21, 2026
