ZLZydus Lifesciences532321Regulatory approval

Zydus receives USFDA approval for Estradiol and Levonorgestrel Transdermal System, eligible for 180-day CGT exclusivity

Zydus Lifesciences has received USFDA final approval for its ANDA for Estradiol and Levonorgestrel Transdermal System, designated a Competitive Generic Therapy, on 21 October 2026.

By ScoutQuest · Wed 21 Oct 2026, 11:13 AM IST · 1 min read

USFDA Final Approval Date

21 October 2026

ANDA Updates and Approvals

458 approvals and 516 ANDAs shared with the USFDA as on 30 September 2026

Annual U.S. Sales (IQVIA MAT Aug-2026)

approximately USD 45.7 mn

Release

Press release

📌 The USFDA has designated the ANDA for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day, a Competitive Generic Therapy; the release names the reference product as Climara Pro Transdermal System 0.045 mg/0.015 mg per day.

🏭 Zydus says the Estradiol and Levonorgestrel Transdermal System, used for moderate to severe symptoms of menopause and for prevention of osteoporosis in postmenopausal women, will be manufactured at the group's plant at Moraiya, near Ahmedabad, Gujarat.

📌 Zydus says the group now has 458 approvals and has so far shared 516 ANDAs with the USFDA as on 30 September 2026; the company cites IQVIA MAT Aug-2026 data showing annual U.S. sales of approximately USD 45.7 mn for this product.

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